Total 8 job vacancies by Merit Medical Singapore Pte. Ltd.

JOB TITLE

Product Engineer

DEPARTMENT

Engineering

ACCOUNTABILITY

Section Leader, Product Engineering

PURPOSE OF JOB

The incumbent will be responsible for the design change controls and product sustaining engineering initiatives. He / She shall ensure that the product designs are validated per customer requirements, including domestic and international regulatory standards.

Utilize technical, project and leadership skills in the development, improvement and optimization of critical care products such as transducers and catheters. Apply technical principles, theories and concepts, as well as problem solving capabilities to resolve product design issues. Maintain design history files, determine test methods requirements, design verification, perform failure mode effect analysis and implement product-related solutions that improves performance and/or quality, as well as address shelf life requirements.

Provide technical support for existing products with issues relating to regulatory compliance, customer complaints, process improvement and CAPA resolution.

Keep abreast of potential new technologies to enable the design of new materials and capabilities. Leverage existing technologies to advance our core businesses while supporting the development of new products.

JOB FUNCTION

• Participate in Product Engineering efforts to validate / verify product design per customer requirements.
• Manage cost of sustaining engineering projects assigned.
• Make timely reports of progress, noting deviations from time or cost plans or customer design requirements.
• Coordinate development efforts with packaging engineering, process engineering, and all other departments that participate in product development.
• In own field of scientific / engineering competence, maintain up-to-date familiarity with developments through attendance at professional meetings, literature and consultations.
• Assist in anticipating, answering and alleviating any customer dissatisfaction with a product.
• Support cost reduction programs and provide technical line support for existing product lines.
• Establish / maintain a base of knowledge of customer requirements through literature, customer visits, etc.
• Comply with all local, state, federal, and Merit safety regulations / policies / procedures.
• Comply with all quality policies / procedures / practices through consistent application of sound Quality Assurance principles.
• Other projects as assigned.

INTERACTION

• Internal communication with all levels of associates.
• External liaison with inter-companies, customers and vendors.

JOB SPECIFICATIONS

• Degree in Bio-Medical / Mechanical / Electrical Engineering.
• Minimum 3 years’ experience of product / process engineering in a medical device company or related industry.
• Experience in product design with thermoplastic knowledge, preferably in medical device industry, will be an advantage.
• Knowledge in CAD Design / SolidWorks and statistical methods.
• Excellent interpersonal and communication skills

· Lead automation projects including equipment upgrade, and assembly process productivity initiatives.

· To spear head the automation initiatives to ensure the machine design, cycle time, project lead time and cost meet the requirements

· Provide automation engineering expertise by analyse production processes, develop automation solution and achieving equipment reliability and process capability.

· Manage optimal deployment of engineering resources and efficient use of the budget.

· Lead the validation activities and projects by providing necessary engineering support and resources.

· Plan and execute equipment upgrade by embarking on structured equipment risk assessment and prioritization.

· Work with cross functional teams to achieve equipment effectiveness and improve process capability through process enhancement and validation.

· Work with team to execute continuous improvement projects to minimize operational disruption and achieve productivity savings.

· Accountable for capital expenditure initiation and spending control

· Maintain a safe and healthy work environment by complying with all related safety regulations.

INTERACTION

Internal parties: Required to communicate effectively with all levels of associates.

External parties: · Required to communicate with other Plants, Corporate / Regional/Businesses, suppliers subcontractors and government agencies as and when required.

JOB SPECIFICATIONS

Education:

· Minimum Degree in mechanical / Electrical engineering/ Material Science with 5-10 years’ experience in automation and assembly processes. Preferably from Medical device / Pharmaceutical industries.

Relevant Experience:

· Familiarization with assembly process, automation, tooling & fixtures designs are desired.

· Experience in project management; as well as validation are preferred.

· Knowledge on Automation machine design and PLC programming.

· Working knowledge on cGMP manufacturing setting

Others:

· Technical specialization in assembly/ automation process preferred.

JOB TITLE

Technician

DEPARTMENT

Production

PURPOSE OF JOB

Purpose of this position is to provide technical support for daily manufacturing operation to meet Safety, Quality, Delivery, Costs and Inventory targets. He shall also ensure all equipment are well maintained by ensuring the performance of schedule preventive maintenance and support process engineers.

JOB FUNCTION

• Responsible for providing technical support to production in carrying out manufacturing plan to meet Plant’s set objectives and ensure that all technical activities is in compliance with all local laws and practices, and in conformance with all relevant company’s policies and procedures.
• Supports in all engineering issues related to respective processes. Is responsible for all maintenance and troubleshooting to ensure smooth operations on the production floor.
• Assists in machine and equipment improvements and upgrading programs.

Support production team in identifying and carrying out continuous improvement to assembly processes, equipment/machines efficiencies, production capacity and utilization, production yield, process quality control, workplace safety and health,5S and other production related activities

• Participate in the Lean initiatives and attend Tier 2 Tier team meeting (SQDCI) as part of continuous improvement activities with related to the Merit Business Excellence System (MBES)

INTERACTION
Internal parties: • Required to communicate effectively with all levels of associates.

External parties: • Required to communicate with other Merit Medical Plants, suppliers subcontractors and government agencies as and when required.

JOB SPECIFICATIONS

Education:

NTC / ITC in Engineering / Manufacturing

Relevant Experience:

Minimum of 3 years similar manufacturing / engineering work experiences of which minimum of 1 years is in cGMP manufacturing environment.

Others:

• Process knowledge in manufacturing assembly and equipment maintenance
• Good teams player and strong skill in trouble shooting equipment failure and technical issues.

Position Description

Responsible for developing and implementing the overall sales strategy to achieve the company's goals and objectives in the assigned product lines – Singapore and Malaysia.

Overview of Responsibilities

• ­ Achieve Sales targets
• ­ Manage customer relationships
• ­ Develop market intelligence
• ­ Grow the market and launch new products
• ­ Foster communication
• ­ Comply Merit policy and local regulations

About the company

Founded in 1987, Merit Medical Systems, Inc. (NASDAQ: MMSI) is engaged in the development, manufacture and distribution of proprietary disposable medical devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy. Merit serves client hospitals worldwide with a domestic and international sales force and clinical support team totalling in excess of 500 individuals. Merit employs approximately 7,000 people worldwide with facilities in South Jordan, Utah; Pearland, Texas; Richmond, Virginia; Malvern, Pennsylvania; Rockland, Massachusetts; Aliso Viejo, California; Maastricht and Venlo, The Netherlands; Paris, France; Galway, Ireland; Tijuana, Mexico; Joinville, Brazil; Markham, Ontario, Canada; Melbourne, Australia; Tokyo, Japan; Reading, United Kingdom; Johannesburg, South Africa; Beijing & Hong Kong, China; Seoul, Korea; Kuala Lumpur, Malaysia; Taipei, Taiwan; Jakarta, Indonesia; Ho Chi Minh City; Vietnam; Bangkok, Thailand and Singapore.

Job Responsibilities

Accountability 1: Achieve and exceed sales targets and forecasts on a quarterly basis

• Ÿ Prepare and execute business plans and key account plans to meet sales targets on quarterly basis
• Ÿ Identify and evaluate new opportunities for growth
• Ÿ Prepare and submit sales reports and sales forecasts.
• Ÿ Manage, direct, monitor and assess current business partners to ensure a cohesive and effective distribution channel established and upgraded
• Ÿ Ensure business objectives are well communicated, committed and delivered
• Ÿ Develop and recruit new business partners to meet the business objectives

Accountability 2: Manage Customer Relationships

• Identify key decision makers and influencers and develop and leverage relationships to support the introduction of Merit products
• Establish, develop and foster relationships with all key customers to increase the market share
• Build and leverage customer relationships with current and potential customers in order to achieve sales targets
• Lead the preparation of relationship management plans for key clinics/customers
• Develop and update key account profiles with KOL development plans

Accountability 3: Drive Market Growth & Launch new product

• Manage and implement new product launches in SG&MY to ensure growth.
• Support, participate and attend key meetings, education, conferences, trade shows and training opportunities to increase awareness of Merit branding and products.
• Manage the product portfolio to optimise business opportunities in each market
• Monitor the business and market trend, and seeking new opportunities
• Cooperate with SEA MD and Strategic Marketing team to execute SG&MY launch center project

Accountability 4: Develop market intelligence

• Develop knowledge of competitor practices and activities; identify strategies to counteract themAttend trade shows, conferences and congresses in the region
• Be the eyes and ears of the company regarding all activities in the territory
• Provide periodic market intelligence reports and updates on competitive activities
• Quarterly market access update; focusing on key practices such as PCI, PTA, PAD & varicose veins

Accountability 5: Reporting Requirements and Communications

• Update and report in-depth analysis of product, market and business partner (distributors and institutes)
• Weekly highlights with key market activities
• Monthly reports and progress against strategic plans
• Foster the communication among SG&MY Team and the broader Merit Asia team
• Ensure effective communication between Merit and business partners (e.g. product update, policy and market update)

Education and Experience

• Bachelor Degree in Science, Biomedical or Life Science
• Minimum of 7 years in a successful medical device sales role, experience in selling interventional cardiology & radiology or related products will be preferred
• Ambitious, result-oriented and able to work under pressure
• Professional, confident and resilient personality with the ability to build and maintain effective business relationship
• Good command of spoken and written English
• Ability to work both independently and collaboratively in a cross-functional and team-oriented environment

Position Description

Build up Merit Medical's medical affairs competency in Asia to support aggressive business expansion. Establish medical partnership to external and internal customers: provide supports to HCPs to ensure sound clinical and scientific knowledge and awareness of Merit's products; provide support and consultation to sales & marketing for business success.

About the company

Founded in 1987, Merit Medical Systems, Inc. (NASDAQ: MMSI) is engaged in the development, manufacture and distribution of proprietary disposable medical devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy. Merit serves client hospitals worldwide with a domestic and international sales force and clinical support team totaling in excess of 300 individuals. Merit employs approximately 6,000 people worldwide with facilities in South Jordan, Utah; Pearland, Texas; Richmond, Virginia; Malvern, Pennsylvania; Rockland, Massachusetts; Aliso Viejo, California; Maastricht and Venlo, The Netherlands; Paris, France; Galway, Ireland; Beijing, China; Tijuana, Mexico; Joinville, Brazil; Markham, Ontario, Canada; Melbourne, Australia; Tokyo, Japan; Reading, United Kingdom; Johannesburg, South Africa; and Singapore.

Job Description

As a Senior Medical Affairs Associate under our Strategy and Marketing Team, you will be responsible for providing medical and scientific support for our products.

Your job responsibilities will be, but not limited to:

1.Medical Strategy

• Develop Strategic Scientific Programs to address unmet clinical needs in our product portfolios eg advisory board meeting, clinical studies and publication
• Support Merit sponsored research/ IIT and may serve as a study lead
• Provide Medical inputs and bring in customer insights from the medical perspective and support to the execution of the operating plans.
• Communicate customer feedback on product development and life-cycle strategies

2. Key Stakeholder Management

• Drive KOL mapping and development plan
• Interact with & develop professional relationships with KOL and medical advisors/ institutes on clinical practice
• Communicate scientific data to healthcare professionals and have in-depth discussions
• Provide proactive updates and medical input to internal stakeholders

3. Medical Engagement and Data Generation

• Generate medical insights through advisory boards/expert meetings, publications, scientific engagements with HCPs and other medical activities such as early access programs
• Support the generation of real-world data for Merit Medical Products
• Work with investigators to evaluate their IIT proposals
• Execute Medical Affairs Tasks as assigned

Requirements:

• Degree holder in Medical Science or related discipline

• Advanced degree preferred or strong demonstration of relevant educational and professional training

• At least 4 years' relevant experiences, preferably in medical device industry

• Demonstrated ability to be knowledgeable in specific disease area

• Experience in clinical study management and good knowledge of GCP

• Proficiency in Cantonese, English & Mandarin

• Excellent analytical, project management, influential and communication skills

• Multi-task effectively and a good team player

• Sound computer skills

• Willing to Travel

• Candidate with less experience would be assigned as Medical Affairs Associate

ABOUT THE COMPANY

Founded in 1987, Merit Medical Systems, Inc. (NASDAQ: MMSI) is engaged in the development, manufacture and distribution of proprietary disposable medical devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy. Merit serves client hospitals worldwide with a domestic and international sales force and clinical support team totaling in excess of 300 individuals. Merit employs approximately 6,000 people worldwide with facilities in South Jordan, Utah; Pearland, Texas; Richmond, Virginia; Malvern, Pennsylvania; Rockland, Massachusetts; Aliso Viejo, California; Maastricht and Venlo, The Netherlands; Paris, France; Galway, Ireland; Beijing, China; Tijuana, Mexico; Joinville, Brazil; Markham, Ontario, Canada; Melbourne, Australia; Tokyo, Japan; Reading, United Kingdom; Johannesburg, South Africa; and Singapore.

PURPOSE OF JOB

Subject matter expert in the current regulatory requirements and strategies for the South-east Asia (SEA) countries, namely Singapore, Malaysia, Indonesia, Thailand and Vietnam.

Responsible for the daily operations of regulatory affairs and ensuring regulatory compliance within SEA countries stated above. Obtaining the regulatory approvals from government agencies for commercial distribution of Merit’s Medical Devices. Conducting product change assessment and obtaining the approval for the reportable changes.

Handling product complaints and managing adverse event reporting and any product recalls.

JOB FUNCTION

1. Pre-market Activities

· Provide independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new or changed product launches.

· Strategizing the regulatory plans, submission, and approval of medical device applications for all new products and life cycle management in SEA.

· Writing and maintaining the regulatory submission dossier according to the local regulatory requirement. Submitting and obtaining the approval through quality responses and effective lobbying of the local regulatory agencies.

· Reviewing product change assessment and providing the regulatory impact with its associate information to the change management team. Preparing the submission dossiers for the reportable changes.

· Prioritizing and organizing multiple projects with competing priorities.

· Maintain product registration record and product registration database to ensure proper documentation and record filing for business partner countries and global team.

2. Post-Market Activities

· Manage post-market surveillance activities (complaints handling, adverse event reporting) in accordance with the local authorities’ regulatory requirement.

· Support local Field Safety Corrective Actions and/or Product Recall.

· Monitor and report adverse events and/or Field Safety Corrective Actions to the relevant regulatory authorities within the SEA.

3. Regulatory Intelligence

· Maintain current knowledge and keep abreast with the latest updates within the SEA relating to Merit Medical products. Ensuring the company is aware and able response timely to comply with the necessary changes.

· Implements and drives any new medical device requirement within the quality system environment.

4. Partnering with Stakeholders

· Leads and/or works within department and/or cross functional teams in achieving regulatory affairs initiatives to support departmental goals in alignment to Plant's vision, objectives and shared values.

· Develop effective working relationship with Global Regulatory Lead, Site Specialists, cross-functional teams, regulatory consultants and business partners countries.

· Provide regulatory advisory to commercial team to align with product launch strategies and assist in regulatory documents submission for hospital or tender requirements.

· Manage Quality Complaints and coordinate and monitor the pre-market and post-market activities conducted by distributors.

INTERACTION

Internal parties:

· All levels of cross-functional associates and cross-site regulatory counterparts.

External parties:

· Regulatory Affairs Representatives, distributors, relevant Regulatory Bodies / Agency and Notified Bodies.

JOB SPECIFICATIONS

Education:

· Degree holder

· Diploma/Advance Diploma

Relevant Experience:

· Preferably 5 years of relevant experience in medical device, with minimum 3 years relevant experience in regulatory affairs in medical devices.

Others:

· Computer literate, preferably in MS office.

· Ability to lead, supervise and work in a team environment.

· Strong written and oral communication, and technical writing skills

· Good interpersonal skills.

· Strong critical thinking coupled with sound decision making skills in bringing successful resolution to high-impact, complex, and/or cross-functional problems

JOB TITLE

System Administrator – IT Infrastructure Support

PURPOSE OF JOB

Support the system and network administration for all IT systems thus providing a reliable platform and foundation for all IT business applications. Responsibilities include efficient and effective performance of all computer hardware, operating systems, cabling, networks and communication and IT infrastructure.

JOB FUNCTION

1. Responsible for Level 1 & 2 IT Infrastructure support, and all aspects of desktop PCs, notebooks, printers, and other peripherals which includes implementation, patching, installation and configuration.
2. Administering, maintaining, and managing the computer systems - Operating Systems and Communication Systems.
3. Maintains documentation regarding security and service records relating to hardware, software, and IT infrastructure.
4. Document, track, and monitor issues in a ServiceNow helpdesk ticketing system to ensure timely resolution.
5. Support and maintain end users account information including rights, security and systems groups.
6. Responsible in managing the data integrity, maintenance and ensure daily data is successfully backup and restore when and there needed.
7. Manage and update all IT assets records periodically.
8. Maintaining and supporting hardware, software and operating systems which in line with the goals and standards of the corporation and IT department policies. This includes installing and upgrading OS of PC hardware and software.
9. Conduct periodic maintenance, audit and compliance for desktop PCs and notebook.
10. Providing support for all office automation products, off-the-shelf application packages, users computing functions and email messaging.
11. Facilitate and liaison with all outsourced vendors for all application remote support and Move-Add-Change requests.
12. Ensuring computer and information security by implementing relevant procedures and standards.
13. Periodic update all Desktop PCs and notebooks to latest security patches and firmware. Conduct regular or quarterly end users’ computer audit and preventive maintenance.
14. Any other work assigned.

INTERACTION

Interfaces with end-users, technical support personnel in the corporation and HQ.

JOB SPECIFICATIONS

A diploma or degree holder preferably in Computer studies, Networking or Communications with at least 3 years working experience in the IT industry. Should be a team player and a reliable, responsible and diligent person that possesses initiative.

• Min. 3 years hand-on experience in administrating Windows Active Directory, DHCP, DNS, MS Exchange, MS Azure and other system related equipment.
• Min. 2 years hand-on experience in maintaining and troubleshooting Cisco network equipment’s, Global Protect VPN and Aruba wireless devices.
• Min. 2 years hand-on experience in managing and configuration of COMMVAULT, Solarwinds, Microsoft Defender, Azure Intune, Endpoint, Microsoft Authenticator, OKTA, OneDrive etc.
• Min. 2 years hand-on experience in Virtualization Technology, VMware, Citrix and SharePoint.
• Preferably holder of MCSA or MSCE, and/with CCNA, and other Management, Service desk skills.

PURPOSE OF JOB

Support the system and network administration for all IT systems thus providing a reliable platform and foundation for all IT business applications. Responsibilities include efficient and effective performance of all computer hardware, operating systems, cabling, networks and communication and IT infrastructure.

JOB FUNCTION

1. Responsible for Level 1 & 2 IT Infrastructure support, and all aspects of desktop PCs, notebooks, printers, and other peripherals which includes implementation, patching, installation and configuration.

2. Administering, maintaining, and managing the computer systems - Operating Systems and Communication Systems.

3. Maintains documentation regarding security and service records relating to hardware, software, and IT infrastructure.

4. Document, track, and monitor issues in a ServiceNow helpdesk ticketing system to ensure timely resolution.

5. Support and maintain end users account information including rights, security and systems groups.

6. Responsible in managing the data integrity, maintenance and ensure daily data is successfully backup and restore when and there needed.

7. Manage and update all IT assets records periodically.

8. Maintaining and supporting hardware, software and operating systems which in line with the goals and standards of the corporation and IT department policies. This includes installing and upgrading OS of PC hardware and software.

9. Conduct periodic maintenance, audit and compliance for desktop PCs and notebook.

10. Providing support for all office automation products, off-the-shelf application packages, users computing functions and email messaging.

11. Facilitate and liaison with all outsourced vendors for all application remote support and Move-Add-Change requests.

12. Ensuring computer and information security by implementing relevant procedures and standards.

13. Periodic update all Desktop PCs and notebooks to latest security patches and firmware. Conduct regular or quarterly end users’ computer audit and preventive maintenance.

14. Any other work assigned.

INTERACTION

Interfaces with end-users, technical support personnel in the corporation and HQ.

JOB SPECIFICATIONS

A diploma or degree holder preferably in Computer studies, Networking or Communications with at least 3 years working experience in the IT industry. Should be a team player and a reliable, responsible and diligent person that possesses initiative.

• Min. 3 years hand-on experience in administrating Windows Active Directory, DHCP, DNS, MS Exchange, MS Azure and other system related equipment.
• Min. 2 years hand-on experience in maintaining and troubleshooting Cisco network equipment’s, Global Protect VPN and Aruba wireless devices.
• Min. 2 years hand-on experience in managing and configuration of COMMVAULT, Solarwinds, Microsoft Defender, Azure Intune, Endpoint, Microsoft Authenticator, OKTA, OneDrive etc.
• Min. 2 years hand-on experience in Virtualization Technology, VMware, Citrix and SharePoint.
• Preferably holder of MCSA or MSCE, and/with CCNA, and other Management, Service desk skills.