Job Description Summary
Job Description
We are the makers of possible
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.
The Design Controls Process Engineer is accountable for influencing design control process activities for product development and product maintenance through the application of Quality engineering skills for medical devices. This person will support product development teams from product inception through product launch and maintenance and play an active role in the process ownership to ensure products meet quality standards consistent with both Corporate and business unit policies, while meeting all design control and other regulatory requirements.
This individual monitors internal and external regulatory observations and trends for hardware and software product development.
Responsibilities:
Ensures Design Controls is effectively implemented across the MMS business, particularly for the Infusion Solutions Platform
Serves as subject matter authority on Design Controls for MMS business, particularly for the Infusion Solutions Platform
Leads continuous process improvements and partners with SME’s on key initiatives
Ensures consistent application of design controls activities across all elements of the Quality System (e.g. CAPA, Field Actions, etc)
Identifies IT solutions necessary to support Design Controls and works with the IT Teams to implement system solutions across BD
Defines metrics and measures for Design Controls
Establishes training requirements and orchestrates training for Design Controls
Monitors performance of Design Controls and reports to senior leadership
Monitors industry surveillance audit outcomes and takes necessary actions to align process to applicable new or revised regulatory requirements and standards
Monitors internal and external audit observations within BD, identifies the appropriate cause and implements fixes across the enterprise for Design Controls
Works with standards committee to monitor for external regulatory changes. Determines need for changes to policy, procedure and practices based on regulatory changes and implements where appropriate
Supports regulatory inspections and audits
Participate collaborative community (cross site/cross functional network of SMEs) which will support and drive change for Design Controls
Education and Experience:
Requires a minimum of a BS/MS degree in life science, engineering or other relevant discipline.
At least 8 years of experience in a Class I/II/III medical device with specific experience in Design Controls
Strong mastery of FDA CFR 820.30 and ISO 14971 required.
Familiarity with ISO 13485, IEC 62366, 60601, and 62304 desired.
Strong background in Design Controls in relation to product design and development.
Strong background in Software compliance requirements
Proven ability as a change agent to drive improvements across a large organization.
Strong technical writing experience required.
Excellent problem solving and analytical skills.
Ability to develop creative approaches and solutions necessary to resolve complex problems.
Strong communicator capable of interfacing at senior levels.
Understanding of the application of quality systems to the medical device industry.
Ability to work effectively and influence leading decision makers across diverse areas of BD and manage complex structures.
Articulate with ability to influence others and significantly promote and/or negotiate in situations that involve recognizing and responding to underlying concerns where others need to be persuaded to accept compromised solutions.
Primary Work Location and Additional Considerations:
USA CA - San Diego TC Bldg C&D
We are interested in every qualified candidate who is eligible to work in the United States. However, we are not able to sponsor visas' at this time.
We are interested in every qualified candidate who is eligible to work in the United States. However, we are not able to provide Relocation assistance at this time.
We encourage Candidates near our BD Location of: San Diego, CA to apply for this Hybrid role.
This is a Hybrid role that requires you to be at your assigned worksite 3 days out of the week and up to 2 days from home. Local policies may apply. BD may change your work arrangement based on business needs.
Remote Work arrangements may be considered for the right Candidate.
Anticpated Travel of about 20%.
At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.
Salary ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary offered to a successful candidate is based on experience, education, skills, and actual work location. Salary ranges may vary for Field-based and Remote roles.
For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why Join Us?
A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.
To learn more about BD visit https://bd.com/careers
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
PDN
Primary Work Location
USA CA - San Diego TC Bldg C&D
Additional Locations
Work Shift
At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.
Salary ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary offered to a successful candidate is based on experience, education, skills, and actual work location. Salary ranges may vary for Field-based and Remote roles.
Salary Range Information
$151,400.00 - $249,800.00
