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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in sustaining engineering for medical devices, with a strong focus on design controls, risk management, and regulatory compliance. Capable of leading cross-functional initiatives and influencing product strategy while ensuring patient safety and market access.
Highest-signal resume keywords
Sustaining EngineeringDesign Controls (21 CFR Part 820, ISO 13485)Risk Management (ISO 14971)Regulatory SubmissionsTechnical Documentation
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Mechanical EngineeringBiomedical EngineeringSystems EngineeringDesign Verification and ValidationStatistical AnalysisData AnalyticsRoot Cause InvestigationsPost-Market SurveillanceClinical Use ConsiderationsProduct Lifecycle Management
Soft Skills
Excellent CommunicationAnalytical ThinkingSystems ThinkingInfluencing Cross-Functional TeamsTechnical Mentorship
Tools & Technologies
Minitab
Industry Keywords
Medical Device IndustryGlobal Product RegistrationsMarket ExpansionCompliance InitiativesProduct EnhancementsPatient SafetyProduct StrategyTechnical Decision-MakingDesign Change DocumentationBiocompatibility Principles
About the role
Key responsibilities & impact- Lead or serve as the technical lead for sustaining engineering projects supporting global product portfolios
- Evaluate product designs against evolving clinical, customer, regulatory, and business requirements
- Identify opportunities for product and process improvement
- Develop and implement technical solutions supporting global product registrations, market expansion, compliance initiatives, and product enhancements
- Lead technical assessments related to design changes, component obsolescence, supplier changes, manufacturing improvements, and risk mitigation
- Apply design control, human factors, usability, and risk management principles to changes affecting released products
- Support regulatory submissions, technical files, risk analyses, and design change documentation
- Leverage post-market surveillance, customer feedback, and clinical insights to drive continuous product improvement
- Facilitate technical decision-making while balancing customer needs, patient safety, regulatory requirements, business objectives, and implementation feasibility
- Serve as a technical mentor and subject matter expert
- Influence product strategy, technical decision-making, and lifecycle management across multiple products and geographies
- Enhance product performance, support global market access, mitigate risk, and ensure continued product portfolio success
Requirements
What you’ll need- Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Systems Engineering, or a related technical discipline with 8+ years of relevant experience; or medical device industry experience required
- Demonstrated experience supporting commercially released medical devices through lifecycle management, design changes, or sustaining engineering initiatives
- Strong knowledge of Design Controls (21 CFR Part 820, ISO 13485) and Risk Management (ISO 14971)
- Working knowledge of biocompatibility principles (ISO 10993), clinical use considerations, and regulatory requirements impacting product design and market access
- Experience supporting global regulatory submissions, product registrations, and technical documentation
- Ability to perform complex technical evaluations and develop practical, compliant engineering solutions
- Understanding of interactions between product design, materials, manufacturing processes, patient safety, regulatory requirements, and clinical performance
- Strong analytical and systems-thinking capabilities
- Excellent communication skills with ability to translate complex technical information across organizational levels
- Ability to evaluate technical, regulatory, clinical, and business tradeoffs
- Proven ability to influence cross-functional teams and drive alignment without direct authority
- Preferred: Master's degree in a related engineering discipline with 6+ years of relevant experience
- Preferred: Advanced degree in Mechanical Engineering, Biomedical Engineering, Systems Engineering, or related discipline
- Preferred: Experience supporting global registration expansion and international regulatory requirements
- Preferred: Experience with design verification and validation, root cause investigations, post-market surveillance, and complaint analysis
- Preferred: Knowledge of plastics engineering, fluid mechanics, infusion systems, medical device materials, or high-volume manufacturing
- Preferred: Experience with statistical analysis and data analytics tools such as Minitab
- Preferred: Ability to lead complex cross-functional initiatives and influence technical strategy across multiple products or platforms
Benefits
Comp & perks- Medical coverage
- Health Savings Accounts
- Flexible Spending Accounts
- Dental coverage
- Vision coverage
- Hospital Care Insurance
- Critical Illness Insurance
- Accidental Injury Insurance
- Life and AD&D insurance
- Short-term disability coverage
- Long-term disability insurance
- Long-term care with life insurance
- Anxiety management program
- Wellness incentives
- Sleep improvement program
- Diabetes management program
- Virtual physical therapy
- Emotional/mental health support programs
- Weight management programs
- Gastrointestinal health program
- Substance use management program
- Musculoskeletal surgery, cancer treatment, and bariatric surgery benefit
- BD 401(k) Plan
- BD Deferred Compensation and Restoration Plan
- 529 College Savings Plan
- Financial counseling
- Baxter Credit Union (BCU)
- Daily Pay
- College financial aid and application guidance
- Paid time off (PTO), including all required State leaves
- Educational assistance/tuition reimbursement
- MetLife Legal Plan
- Group auto and home insurance
- Pet insurance
- Commuter benefits
- Discounts on products and services
- Academic Achievement Scholarship
- Service Recognition Awards
- Employer matching donation
- Workplace accommodations
- Adoption assistance
- Backup day care and eldercare
- Support for neurodivergent adults, children, and caregivers
- Caregiving assistance for elderly and special needs individuals
- Employee Assistance Program (EAP)
- Paid Parental Leave
- Support for fertility, birthing, postpartum, and age-related hormonal changes
- Bereavement leaves
- Military leave
- Personal leave
- Family and Medical Leave (FML)
- Jury and Witness Duty Leave
- Incentives
- Performance-based culture
- Reward and recognition opportunities