Medica is seeking a Senior Mechanical Engineer, Team Lead to serve as a player-coach within our cross-functional Product Development team. In this role, you will directly lead a team of 2–3 mechanical engineers while remaining hands-on in the design, development, and evolution of Medica’s laboratory and clinical analyzers. You will combine deep technical expertise with day-to-day team leadership, ensuring both engineering excellence and DHF integrity across all phases of product development.

Roles and Responsibilities:Team Leadership:

• Directly lead, mentor, and provide day-to-day technical guidance to a team of 2–3 mechanical engineers, including workload prioritization and performance support, with potential to grow into direct performance management responsibilities.
• Foster a collaborative, innovative, and accountable engineering culture.
• Set clear objectives and performance expectations for team members.
• Communicate project status, risks, and milestones to stakeholders and project management.

Engineering and Design:

• Lead, execute, and contribute to all Mechanical Engineering activities from concept to production, including specification, design, prototyping, verification, validation, and testing.
• Actively participate on cross-functional project teams through all phases of product development to ensure successful execution of innovative, best-in-class designs.
• Lead design reviews, FMEA analyses, and other DFx-related activities.
• Analyze technical issues using methodical problem-solving techniques and provide root cause analysis and solutions.
• Oversee compliance with V&V activities, including offsite test management.
• Exhibit role model behaviors of thorough engineering practices and cradle-to-grave ownership.

Documentation and Regulatory Compliance:

• Support maintenance of the Design History File (DHF) throughout the product development lifecycle, ensuring all documentation is complete, traceable, and audit-ready.
• Write functional specifications, design verification plans, and functional test procedures.
• Ensure all documentation complies with applicable QMS requirements per current revisions of ISO 13485 and 21 CFR Part 820/QMSR.
• Proficiency in processing design change notices (DCNs) and maintaining associated documentation.

Required Skills:

• Strong technical expertise in mechanical design, simulation, and testing within medical device or laboratory instrument development.
• Demonstrated ability to lead, mentor, and develop engineers in a team environment.
• SolidWorks CAD experience with best practices for part design, advanced assemblies, complex configuration management, and proficiency with SolidWorks Simulation and Ansys FEA tools.
• Hands-on experience developing proof-of-concept models and designing production components (cast, injection mold, machined, stamped, etc.).
• Strong proficiency in root cause analysis, FMEA, and DHF documentation management.
• Familiarity with current revisions of ISO 13485 and 21 CFR Part 820/QMSR.
• Excellent verbal and written communication skills, including ability to create PowerPoint presentations and technical documents.
• Strong organizational skills and ability to work effectively with cross-functional teams.
• Creative problem solver with excellent analytical skills.

Education:

• Bachelor’s Degree in Mechanical Engineering required; Master’s Degree (MS) is a plus.

Experience:

• Minimum of 5 years in medical device or laboratory equipment development across the full product lifecycle, from inception through maturity, with at least 1–2 years in a lead or mentoring capacity.

Pay: $102,000.00 - $125,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Parental leave
• Referral program
• Retirement plan

Work Location: In person