BD (Becton, Dickinson and Company) Staff Systems Engineer in San Diego, California
Job Description Summary
Systems Compliance Engineering will assume various Compliance Engineering responsibilities including interface with third party test organizations, standards compliance and standards evaluation for existing and new products and processes. Position supports both existing in-market products and new product lines in active development.
Essential Duties and Responsibilities:
This position works closely with Product Development Engineers to prevent compliance issues by reviewing design data; identifying and resolving product and engineering design issues; identifying short-term and long-range issues; researching and identifying applicable regulatory and industry compliance standards and codes; developing compliance policies.
Translates the applicable medical device standards and regulations to SMART requirements.
Determines compliance by establishing compliance test standards; conducting and witnessing tests; performing diagnostic procedures; measuring performance; troubleshooting failures.
Develops compliance plans for Type testing for IEC 60601-1 and its applicable collateral and particular standards by researching, selecting, and applying compliance engineering concepts, techniques, and criteria; adapting and modifying compliance engineering options; developing and evaluating new compliance methodologies.
Tracks, assesses, and manages testing and implementation of changes to domestic and international standards, regulations and guidance documents that the company must comply with.
Participates as member of the design team. Activities may include assisting with defining design inputs; designing components and processes; verifying that design outputs satisfy design inputs.
Develops company policies and procedures that help BD achieve its quality policy and compliance with domestic and international regulations.
Provides system/product-level feasibility and risks assessments.
Facilitates cross-functional knowledge and experiences to promote the understanding and resolution of in-market and product development issues.
Responsible for coordination of system-level product development and its integration
Identify opportunities and drives continuous improvement efforts.
Apply and assert DFSS best practices on all projects.
Applies proficient computer skills in the use of Microsoft Office and database applications (e.g. Excel and MiniTab)
Bachelor of Science Engineering or technical degree. A post graduate degree is desired.
10 years related experience and/or training; or equivalent combination of education and experience. Previous experience or employment by recognized test labs such as CSA, UL, TUV, Intertek is preferred.
Knowledge of medical device regulations such as FDA (21CFR 820), EU, … and related IEC/ISO standards such as ISO 13485, IEC 60601-1, ISO 14971.
Familiarity or expose to handling FDA complaints, product labeling and associated regulatory activities is required.
A strong technical background within Systems Engineering, medical device development, or similar.
Experience with Systems Engineering, requirements management, systems integration and testing, system architectural planning and design, Reliability Engineering, Project Management, and Failure Modes Effects Analysis, Fault tree analysis.
Ability to work independently and as a member of a team.
Ability to lead multi-discipline engineering teams.
Excellent communication skills with the following departments: interdepartmental (with fellow engineers), cross-functional (with Marketing, Clinical Representatives, Software Engineers, Test Engineers, and Quality Engineers)• Must have very strong writing skills.• Attention to detail paramount.
Experience coaching junior associates a plus.
Primary Work LocationUSA CA - San Diego TC Bldg C&D
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