What You Can Expect
As a Senior Mechanical Engineer, you will act as a senior technical individual contributor and technical lead for complex mechanical engineering activities related to existing products and manufacturing processes. This role requires deep engineering expertise, strong independent judgment, and the ability to lead technical work across cross-functional teams without formal people management responsibilities.
You will be expected to identify technical risks, diagnose complex product and process issues, develop robust engineering solutions, and guide implementation in a regulated medical device environment. Success in this role requires a hands-on, analytical engineer who can move effectively between design, manufacturing, quality, supplier, and regulatory considerations.
How You'll Create Impact
- Lead the technical execution of product improvement initiatives for existing products, from problem definition through engineering assessment, solution development, verification, implementation, and release
- Serve as a technical contributor for cross-functional activities involving engineering, production, quality, suppliers, and new product development partners
- Own complex engineering analyses to support design changes, production issue resolution, and product performance improvement, including dimensional, tolerance stack-up, functional, structural, and failure mode assessments
- Independently investigate product and process nonconformances, customer complaints, and technical issues by identifying root causes, assessing risk, and recommending practical, data-driven corrective actions
- Define, plan, and execute verification and validation activities associated with engineering changes using scientifically and statistically sound methods
- Develop test methods, protocols, and engineering rationales to support product modifications, design decisions, and manufacturing improvements
- Evaluate the impact of design or process changes on product performance, manufacturability, reliability, quality, and regulatory compliance
- Coordinate implementation and transfer of product improvements to suppliers and manufacturing teams, ensuring technical requirements are clearly defined and effectively executed
- Contribute technical expertise to risk management activities, including FMEA and related engineering risk assessments.
- Support CAPA, nonconformance, and complaint investigation activities with strong technical analysis and clear documentation
- Provide engineering documentation and technical support for regulatory submissions, product certifications, and change control activities, including support for 510(k)-related documentation where applicable
What Makes You Stand Out
- Significant experience in the medical device industry or another highly regulated manufacturing environment
- Experience working within an ISO 13485-regulated environment
- Strong experience with engineering change implementation for released products
- Experience with risk management activities, including DFMEA and structured engineering risk evaluation
- Experience planning and executing verification and validation (V&V) activities
- Familiarity with 510(k) submission support activities and the documentation expectations associated with regulated product changes
- Strong capability in tolerance stack-up analysis for mechanical assemblies
- Strong knowledge of geometric dimensioning and tolerancing (GD&T)
- Hands-on experience with prototyping, inspection, manufacturing support, and supplier collaboration
- Strong root-cause investigation and corrective action skills
- Strong technical writing and documentation skills in a regulated environment
Your Background
- Bachelor's degree in Mechanical Engineering or a related engineering discipline
- Minimum of 5 years of relevant engineering experience, or an equivalent combination of education and experience
- Strong in-depth mechanical engineering fundamentals, including design analysis, failure analysis, and manufacturability
- Proficiency with 3D CAD tools; SolidWorks experience preferred
Travel Expectations
This is a senior technical individual contributor role and does not include direct people management responsibility.
Travel up to 30%
