About the position
The Principal Engineer – New Product Introduction is a highly experienced expert role responsible for driving cross-functional strategy from design concept through successful commercialization and global manufacturing deployment. This position involves providing strategic inputs and technical expertise to support a portfolio of projects, focusing on Overall Product Launch Orchestration & Design Transfer Strategy. This role plays a critical part in ensuring the successful integration of all elements (product design, process, automation, quality controls, supply chain, logistics) for successful, scalable, cost-effective, and compliant new product introductions and technology transfers into manufacturing Value Streams. In addition to the above, The Principal Engineer provides strategic technical guidance across product platforms leads global design transfer initiatives and drives Lean Six Sigma and process excellence throughout the product lifecycle. They are expected to independently lead complex projects or guide multidisciplinary teams to solve high-impact technical challenges in a regulated environment. Depending on the department, this role may include oversight of project teams or mentorship of junior engineers and technical staff.
Responsibilities
- Lead the overall strategic plan and execution for design transfer and launch readiness of new products into manufacturing.
- Provide strategic guidance and technical direction in management and executive meetings.
- Partner with various teams to align product requirements with global production capabilities.
- Ensure new products are designed for efficient and cost-effective manufacturing.
- Provide technical mentorship and lead resolution of complex new product/process issues.
- Ensure all newly transferred products meet FDA regulations, ISO standards, and GMP requirements.
- Lead the transfer of technology and processes for new products from R&D to manufacturing.
- Develop and implement New Product Introduction and Transfers standards.
- Serve as the New Product Introduction project technical lead.
- Conduct thorough risk assessments and implement mitigation strategies.
- Lead process commissioning, characterization, qualification, and validation activities.
- Champion continuous improvement through lean six sigma manufacturing principles.
- Lead technology transfers and knowledge-sharing across internal manufacturing sites.
- Foster effective working relationships with senior engineers and leaders.
- Attend business meetings, prepare minutes, communications, and reports.
- Work collaboratively with cross-functional teams.
Requirements
- Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, or related field.
- 20+ years in process development, manufacturing engineering, or product development.
- At least 10 years in the medical device or other highly regulated industry.
- Lean Six Sigma Black Belt (SSBB) certification is required.
- Expertise in manufacturing process architecture and value stream transformation.
- In-depth understanding of Design for Manufacturability (DFM) and statistical analysis.
- Strong knowledge of FDA regulations, ISO 13485, GMP, and risk management practices.
- Exceptional ability to learn new technologies and explain complex engineering problems.
- Proficiency in creating and delivering presentations to executive management.
Nice-to-haves
- Master’s degree preferred.
- Lean Sigma Master Black Belt and Project Management Professional (PMP) certifications are desirable.
- Familiarity with automation, Industry 4.0 concepts, and equipment integration.
Benefits
- Paid vacation
- Paid holidays
- Health, dental and vision benefits
- 401(k) with matching contributions
- Tax advantage savings accounts
- Legal plan
- Voluntary life and AD&D insurance
- Voluntary long-term disability
- Short term disability
- Critical illness and accident insurance
- Parental leave
- Personal leave
- Tuition reimbursement
- Travel assistance
- Employee assistance program
