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Senior Mechanical Engineer, Team Lead

Medica Corporation -
Bedford, MA

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Job Details

Full-time
$102,000 - $125,000 a year
9 days ago

Benefits

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

Qualifications

Developing medical devices
Product design project leadership
Bachelor's degree in mechanical engineering
Managing medical device teams
Teamwork
New product introduction engineering projects
Project engineering
Content creation for technical audiences
Presentation software
Medical device testing
Coaching
Regulatory compliance
CAD design (engineering design task)
Configuration management
Team development
Collaboration with product development teams
Supervising experience
Managing engineering teams
ANSYS
Compliance documentation
Mentoring
Design engineering
Prototype creation
Organizational skills
Leading team collaboration initiatives
FEA
Presentation preparation
Design controls
Biomedical regulatory compliance
Simulation tools

Full Job Description

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

Quick Apply

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