What are the responsibilities and job description for the Sr. Mechanical Engineer, MedTech position at Knowles?
SUMMARY DESCRIPTION:
Are you ready to help shape the next generation of innovation in MedTech R&D? We are seeking a Sr. Mechanical engineer who is energetic and self‑driven to join our growing team. This is an exciting opportunity to advance your career while contributing to cutting‑edge medical technologies used by leading global MedTech companies and fast‑moving startups. You’ll work on a wide variety of mature and emerging technologies, supporting both New Technology Introduction (NTI) and New Product Introduction (NPI) initiatives.
WHAT YOU’LL DO:
Mechanical Design & Development
- Design components, assemblies, and fixtures using PTC Creo
- Develop new products and create design packages from customer inputs
- Optimize designs by working with cross‑functional engineering, quality, and manufacturing teams
Project & Technical Leadership
- Lead mechanical design and development efforts from concept through release
- Collaborate confidently with global manufacturing, metrology, and quality teams
- Define requirements through customer input and reverse engineering of legacy products
Testing, Data, & Simulation
- Develop test processes and coordinate measurement activities
- Perform tolerance analysis and mechanical simulations (Ansys, COMSOL)
- Manage data collection and ensure accurate documentation
Customer & Cross‑Functional Collaboration
- Partner directly with customers on design definition, reviews, and issue resolution
- Work closely across AME, Test Engineering, Quality, and factories
- Support design-for-manufacturability (DFM) and supplier engagement
Documentation & Compliance
- Create and release drawings; support validation (IQ/OQ/PQ)
- Generate reports on testing, metrology, simulations, and analyses
- Ensure compliance with ISO 13485 and other MedTech standards
WHAT YOU BRING - REQUIRED QUALIFICATIONS:
- Bachelor’s in Mechanical or biomedical engineering (Master’s preferred)
- 5 years in medical device design, manufacturing, or process engineering
- Strong mechanical design skills, especially with PTC Creo
- Experience in part/assembly design, drafting, and fixture design
- Knowledge of key manufacturing processes:
- Metal stamping, injection molding, machining
- Plastics, metals, adhesives, plating
- Laser welding/cutting, MIM, automation (preferred)
- Strong analytical skills, including:
- Statistical analysis
- Advanced Excel
- Ability to think deeply through complex engineering problems
- Effective communication and collaboration with customers, suppliers, and cross-functional teams
PREFERRED SKILLS:
- Experience with Class II or III medical devices
- Familiarity with FDA, ISO 13485, EU MDR
- Experience with 2D/3D metrology (X‑ray, OGP, CT scanning)
- Skills in MATLAB, Python, or LabVIEW
- Understanding of magnetic materials and electromagnetics
- Experience with PLM systems (Agile, Windchill, etc.)
WHY JOIN US?
- Opportunity to impact MedTech innovation at a component level, supporting top global OEMs.
- Startup-like agility within a growing organization backed by strong industry presence.
- Significant opportunities for professional development within a growing division of Knowles.
- Competitive compensation and benefits package.
EOE/M/F/D/V