Sr. Engineering Lead
JabilAbout the role
How Will You Make an Impact?
As the Engineering Lead – New Product Introduction (NPI) for Medical Devices, you will play a pivotal role in launching innovative medical products into manufacturing. You’ll be responsible for leading engineering efforts, collaborating cross-functionally with R&D, Regulatory, Quality, Supply Chain, and Manufacturing teams to ensure that products meet design intent, regulatory standards, and launch timelines. Your work will directly contribute to delivering high-quality, life-enhancing medical technologies to market.
What Will You Do?
Lead NPI Projects: Own the technical execution of new product launches, ensuring milestones are achieved on time, within scope and budget.
Team Leadership & Mentorship: Guide and support a team of engineers, fostering a culture of continuous improvement, technical excellence, and collaboration.
Cross-functional Collaboration: Partner with R&D, Quality, Regulatory, Manufacturing, Supply Chain, and Planning to align on product design, process development, and deployment strategies.
Product Deployment: Oversee design transfer from R&D to manufacturing, including prototyping, testing, and process validation activities (IQ/OQ/PQ).
Risk Management: Lead DFx and FMEA efforts to mitigate technical and process risks, ensuring robust design and manufacturing controls.
Regulatory & Compliance: Ensure all engineering and manufacturing processes are compliant with FDA, ISO 13485, CE Mark, and IEC 60601 standards.
Technical Documentation: Develop and review documentation such as DHFs, risk management files, validation protocols/reports, and design transfer packages.
Continuous Improvement: Identify opportunities to improve engineering efficiency, product quality, and time-to-market through best practices and lean methodologies.
How Will You Get Here?
Education:
Bachelor’s degree in Engineering (Mechanical, Electrical, Biomedical, or related field) required.
Master’s degree preferred.
Experience:
Minimum 5+ years of experience in product development, with 2–3 years in a technical leadership or management role.
Proven track record leading NPI projects in the medical device industry, with a deep understanding of the product lifecycle and regulatory landscape.
Experience in the design, prototyping, and validation of electromechanical and disposable/reusable medical devices.
Experience working in a regulated environment with cross-functional teams.
Knowledge, Skills, Abilities:
Proficient in CAD tools (e.g., SolidWorks, AutoCAD); familiarity with simulation and analysis tools.
Solid understanding of manufacturing processes including injection molding, mechanical/PCB assembly, plastic bonding, adhesive dispensing, laser welding, and UV bonding.
Expertise in DFx methodologies (Design for Assembly, Manufacturing, Cost, Test, etc.).
Strong knowledge of medical device standards including ISO 13485, FDA 21 CFR Part 820, IEC 60601.
Excellent leadership, communication, and mentoring skills.
Effective at presenting complex technical concepts to diverse audiences.
Skilled in project management tools and methodologies.
Strong problem-solving skills with a focus on innovation and practical solutions.
Preferred Qualifications:
Experience with medical catheters and related bonding technologies (e.g., plastic, UV, laser).
Familiarity with cleanroom manufacturing environments.
Previous experience supporting regulatory audits and technical file submissions.
Benefits
- Medical, Dental, Prescription Drug, and Vision Insurance with HRA and HSA options
- 401K match
- Employee Stock Purchase Plan
- Paid Time Off
- Tuition Reimbursement
- Life, AD&a
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