We are seeking a highly skilled Product Development Engineer to drive the development of robust manufacturing processes and assembly solutions for new product introductions. This role partners closely with R&D, Operations, and cross-functional engineering teams to ensure products are designed for manufacturability, assembly, quality, scalability, and business success.

The ideal candidate brings deep expertise in Design for Manufacturing and Assembly (DFMA), process development, and technical leadership within a medical device or other highly regulated manufacturing environment. This person will play a key role in launching innovative products by developing efficient, high-quality manufacturing processes and automation strategies that support operational excellence, product quality, and sustainable growth.

Key Responsibilities

New Product Development & Industrialization

• Lead DFMA strategy for new products and product design changes to ensure successful commercialization and transfer to manufacturing.
• Partner with R&D during product development to influence design decisions that improve manufacturability, assembly, quality, and cost.
• Define and develop scalable manufacturing processes, equipment concepts, and assembly methods for new product introductions.
• Lead engineering efforts to build pilot lines and establish capable, efficient manufacturing processes that achieve performance, quality, and OEE targets.
• Support internal and external manufacturing transfer activities, including industrialization planning and factory readiness.

Manufacturing Process Development

• Develop manufacturing processes that meet product requirements, cost targets, and capacity needs.
• Perform DFA, DFMA, DFSS, tolerance stack-up, and risk analyses to optimize designs and reduce manufacturing risk.
• Identify process improvement opportunities for existing manufacturing operations and implement solutions that improve efficiency, quality, and throughput.
• Develop and implement risk mitigation plans for assembly processes and ensure process robustness.

Technical Leadership

• Serve as a subject matter expert in DFMA, assembly engineering, and advanced manufacturing processes.
• Provide technical leadership for cross-functional project teams and lead technical process reviews.
• Guide design teams on best practices for manufacturability, assembly, and process capability.
• Present technical data, recommendations, and project updates clearly to stakeholders across multiple levels of the organization.

Validation, Compliance & Documentation

• Support verification and validation activities for product commercialization, including protocol development, execution, data analysis, and reporting.
• Assist in development of product and process documentation, including design control documentation, process specifications, and inspection/test procedures.
• Ensure all activities comply with applicable quality systems, GMP requirements, and regulatory standards.
• Follow all safety policies, procedures, and site-specific requirements.

Commercialization Support

• Support all technical activities related to new product launch, including:
  • Manufacturing process conceptualization and development
  • Tooling and equipment development
  • Vendor identification and support
  • Make-versus-buy analysis
  • Site selection support
  • Capital equipment planning
  • New product cost estimates
  • Material evaluations
  • Inventory and component planning for development builds

Qualifications

Education

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, or a related technical field with 10+ years of relevant experience, or
• Master’s degree or MBA in Engineering or related field with 8+ years of relevant experience

Required Experience

• 5+ years of experience in advanced manufacturing engineering, product design, or technical leadership, preferably in medical device or other highly regulated industries
• Proven experience applying DFMA principles to product and process development
• Experience leading advanced manufacturing or industrialization initiatives from concept through commercialization
• Experience in process validation, including writing protocols and reports for verification and validation activities
• Strong experience with risk analysis/FMEA, design control, CAD modeling, DFSS, and tolerance stack-up analysis
• Experience with digitalization and automation in manufacturing environments

Preferred Experience

• Medical device industry experience
• Automation and semi-automated manufacturing line experience
• Experience with both manual and semi-automated production processes

Technical Skills

• Working knowledge of design and simulation tools such as SolidWorks, AutoCAD, ProModel, and FlexSim
• Strong understanding of GD&T, technical drawings, and part print interpretation
• Knowledge of tooling, drafting, and manufacturing process development
• Proficiency in statistical methods for DOE, process characterization, and validation
• Ability to analyze technical data and generate clear, concise reports
• Understanding of project planning, budgeting, and capital equipment processes

Core Competencies

• Technical leadership and strong engineering judgment
• Excellent project management, planning, and organizational skills
• Effective communication and presentation skills
• Strong collaboration skills across multidisciplinary and global teams
• Ability to work independently and drive projects from concept to implementation
• Problem-solving mindset with strong attention to detail and execution

Travel

• Up to 25% travel