Senior Mechanical Engineer – MedTech Plastics

Senior Mechanical Engineer – MedTech Plastics

Location: Itasca, IL

Department: MedTech & Specialty Audio (MSA)

About the Role:

Knowles is seeking a Senior Mechanical Engineer – MedTech Plastics to lead the design, development, and commercialization of innovative medical device components and assemblies. This role combines strong mechanical engineering fundamentals with experience in plastic component design, injection molding, and manufacturing processes.

You will work cross-functionally with quality, manufacturing, sales, and application engineering teams to bring products from concept through production while driving performance, reliability, manufacturability, and cost optimization.

Key Responsibilities:

• Lead the design and development of medical device components and assemblies from concept through commercialization.
• Apply mechanical engineering principles to solve complex product design, reliability, and manufacturing challenges.
• Drive Design for Manufacturability (DFM), Design for Assembly (DFA), and cost optimization initiatives.
• Provide expertise in plastic part design, material selection, injection molding, and tooling development.
• Support prototype, verification, validation, and New Product Introduction (NPI) activities.
• Partner with suppliers and manufacturing teams to optimize processes, quality, and production readiness.
• Conduct engineering analyses including tolerance stack-ups, GD&T, risk assessments, and root cause investigations.
• Support design controls, process validations, and regulatory requirements within a medical device environment.
• Collaborate directly with customers on technical reviews, product development, and problem-solving initiatives.

Required Qualifications:

• Bachelor's degree in Mechanical Engineering or related engineering discipline.
• 7+ years of experience in mechanical engineering, product development, or manufacturing engineering.
• Experience leading products from concept through production release.
• Strong knowledge of mechanical design principles, materials, manufacturing processes, and product development methodologies.
• Experience with plastic component design and injection molding processes.
• Proficiency in CAD tools such as Creo, SolidWorks, or equivalent.
• Strong working knowledge of GD&T and tolerance analysis.
• Excellent problem-solving, communication, and project management skills.

Preferred Qualifications:

• Experience in medical devices or other highly regulated industries.
• Knowledge of medical-grade polymers, tooling development, and scientific molding principles.
• Experience with micro-molding, insert molding, over molding, LSR molding, and multi-shot molding.
• 2+ years of experience working closely with the design and DFM of injection molded plastic parts or molds for injection molded parts.
• Experience with metal forming, stamping, and deep draw forming, particularly of small parts.
• Familiarity with ISO 13485, FDA regulations, and medical device quality systems.
• Experience with process validation, Six Sigma, DOE, or statistical analysis tools.
• Experience working with global suppliers and manufacturing partners.

Why Join Knowles?

• Develop technologies that improve and save lives.
• Work on innovative MedTech products from concept to commercialization.
• Partner with leading global OEMs and emerging medical technology companies.
• Join a collaborative, growth-oriented engineering team with significant opportunities for professional development and leadership.

This position is ideal for a strong Mechanical Engineer with plastics expertise who wants to play a key role in shaping next-generation medical device solutions.