Staff Compliance Engineer at Becton Dickinson NA in San Diego, California

Job Description:

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.


We are seeking a Compliance Engineer to work on medical device software and hardware development projects in a variety of settings including infusion pumps, networked devices, and embedded systems. This position will be responsible for ensuring all applicable regulations are met throughout the entire product lifecycle. The successful candidate will be familiar with regulatory requirements conducting gap assessments on new standards such as IEC/EN 62304, ISO/EN 14971, Quality Management Systems in accordance with ISO 13485, FDA 21 CFR 820 and EU MDR 2017/745, IEC/EN/CSA/AAMI 60601-1/80601-1. Experience supporting US FDA 510(K) and international submissions, collaborating with third-party certification agencies, and mapping design requirements to standards, and managing CAPAs.



Responsibilities

• Maintain regulatory compliance by managing the Standard's Master


• Depository List and conducting gap assessments on new standards.


• Support US FDA 510(K) and international submissions.


• Conformity assessment and certification of Basic safety and essential performance of electromechanical medical devices IEC/EN/CSA/AAMI 60601-1/80601-1


• Oversee lab control and certifications.


• Manage CAPA for product stewardship and electrical safety.


• Develop test plans for electrical safety and EMC.


• Ensure appropriate technical documentation exists for each project (e.g., design history files, risk analysis reports, software development records, etc.)


• Review specifications and design documents for conformance to quality system regulations


• Review, evaluate and approve change requests according to established guidelines, based on risk to patient safety or regulatory compliance


• Advise management on compliance matters


• Provide training to compliance engineers on compliance topics


• Stay current on relevant regulatory developments and new technologies

Qualifications

• Bachelor's degree in Computer Science, Electrical Engineering, or related field preferred


• Minimum 8 years' experience working on medical device software and hardware development projects


• Experience working with software according to IEC 62304 standards


• Experience working with IEC/EN/CSA/AAMI 60601-1/80601-1 standards (IEC 61010-1, 2-10,2-101,2-81,2-20, 2-30, 2-31, 2-33; IECEE 60601-, 1-8,1-6,1-11, 2-24 infusion pumps)


• Experience with ISO 14971, ISO 17025, IECEE procedures and audits, IEC 62304 , Usability IEC 62368


• Working knowledge of regulatory requirements such as FDA 510(k) submissions and EU MDR/IVDR


• Strong understanding of development life cycle


• Excellent communication skills, both written and verbal


• Must be able to communicate technical information effectively to both technical and non-technical personnel


• Travel Requirements:

Job Summary

CareFusion is looking for a compliance engineer to work on medical device software development projects in a variety of settings including single-user applications, networked devices, mobile apps, web portals, and embedded systems. This position will be responsible for ensuring all applicable regulations are met throughout the entire product lifecycle. The successful candidate will have experience developing software according to IEC 62304 standards and be familiar with regulatory requirements such as FDA 510(k) submissions and EU MDR/IVDR.



Responsibilities

• Ensure appropriate technical documentation exists for each project (e.g., design history files, risk analysis reports, software development records, etc.)


• Review software specifications and design documents for conformance to quality system regulations


• Perform audits of software development processes and procedures for compliance with internal and external regulations


• Review and approve software change requests according to established guidelines


• Work directly with software developers to ensure appropriate software validation activities are planned and executed


• Evaluate software changes based on risk to patient safety or regulatory compliance


• Advise management on software compliance matters


• Provide training to software developers and other stakeholders on software compliance topics


• Stay current on relevant regulatory developments and new technologies

Qualifications

• Bachelor's degree in Computer Science, Electrical Engineering, or related field preferred


• Minimum 2 years' experience working on medical device software development projects


• Experience developing software according to IEC 62304 standards


• Working knowledge of regulatory requirements such as FDA 510(k) submissions and EU MDR/IVDR


• Strong understanding of software development life cycle


• Ability to read and interpret software code


• Familiarity with software configuration management tools


• Excellent communication skills, both written and verbal


• Must be able to communicate technical information effectively to both technical and non-technical personnel


• Travel Requirements:

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.


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.


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Primary Work Location

USA CA - San Diego TC Bldg C&D



Additional Locations




Work Shift

NA (United States of America)


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 or hourly rate 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 or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.



Salary Range Information

$121,100.00 - $199,800.00 USD Annual Apply Now