Job Description
Lead the strategy and execution of manufacturing engineering activities for new product development within the medical device industry. Responsible for driving design for manufacturing (DFM) principles, ensuring seamless operations integration, and achieving successful industrialization and scale of innovative products from concept through commercial launch. Job duties:
- Lead NPI manufacturing engineering strategy by defining and implementing best practices within new product development, ensuring alignment with business objectives and regulatory requirements.
- Design for manufacturing excellence by partnering with R&D to optimize product designs for manufacturability, cost efficiency, and scalability.
- Process development and capability: Oversee process development, design of experiments (DOE), and validation activities to ensure robust, repeatable, and compliant manufacturing processes.
- Operations integration: Collaborate cross-functionally with Operations, Quality, and Supply Chain to integrate new products into production environments seamlessly.
- Industrialization and scale: Drive readiness for high-volume production, ensuring smooth transition from pilot builds to full-scale manufacturing.
- Ensure continuous improvement by applying Six Sigma engineering principles and maintain Black Belt certification standards to improve process capability and reduce variability.
- Leadership and team development: Build and mentor a high-performing team of manufacturing engineers and technical experts.
- Perform design and manufacturing engineering analysis using geometrical dimensioning and tolerancing and process capability studies.
- Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.
- Perform additional duties as assigned.
Qualifications
- Bachelor’s degree in engineering or science.
- Minimum of fifteen (15) years of relevant professional experience in production, manufacturing engineering, R&D engineering, and process development engineering roles.
- Minimum seven (7) years of management or leadership responsibility/experience.
- Proven track record of design for manufacturing and successful commercial scale-up of new product introductions.
- Strong knowledge of Six Sigma engineering (Black Belt trained and certified).
- Expertise in the design of experiments, process capability, and process development methodologies.
- Experience in medical device manufacturing with deep understanding of regulatory and quality requirements.
- Proven track record of successfully managing complex projects and delivering results on time and within budget.
- Exceptional leadership, written and verbal communication, and stakeholder management skills.
- Proficiency in project management software and tools and MS Office Suite, including Word, Excel, Outlook, and Teams.
Desired Qualifications
- Advanced degree in a relevant field of study.
- Project Management Professional (PMP) certification.
