AuST Group is both a premier medical device design and development firm and a high-volume manufacturer of components and finished devices. We bring broad experience in minimally invasive technologies and deep expertise in cardiovascular catheters. “AuST” is a name symbolizing the gold (Au) standard (ST). We strive to deliver the gold standard in everything we do.
We are seeking an experienced NPI (New Product Introduction) Engineering Manager to lead the successful transfer of new medical device products from development into high volume manufacturing. This role plays a critical part in ensuring products are validated, regulatory requirements are met, and manufacturing processes are optimized for quality, efficiency, and scalability.
The ideal candidate is a strong cross-functional leader who thrives in a regulated medical device environment and brings deep experience in design controls, validation, and manufacturing process development.
Key Responsibilities
- Lead engineering support for product testing and validation activities to support regulatory submissions.
- Manage and drive design transfer activities from development to manufacturing.
- Lead, mentor, and develop a team of engineers, providing technical direction, performance feedback, and project oversight to ensure successful execution of NPI projects.
- Ensure compliance with applicable regulatory requirements (FDA, ISO 13485, and other market-specific regulations).
- Partner closely with Regulatory Affairs to ensure products meet requirements for intended global markets.
- Optimize new manufacturing processes and equipment to support efficient, scalable production.
- Ensure products are designed for manufacturability (DFM).
- Collaborate cross-functionally with Manufacturing, Development, Quality, and Senior Leadership to align project objectives.
- Coordinate with key external partners during product transfer and launch.
- Drive project timelines, manage priorities, and ensure successful execution of NPI initiatives.
Qualifications
Education
Required:
- Bachelor’s Degree in Engineering, Engineering Technology, or related technical discipline (or equivalent combination of education and experience)
Preferred:
- Bachelor’s Degree in Engineering or Engineering Technology with extensive training in Lean and Continuous Improvement methodologies
Experience
Required:
- Minimum 5 years of experience in a medical device manufacturing environment
- Proven project management experience
- Strong understanding of ISO 13485 and FDA QSR requirements
- Knowledge of working with medical device regulations CFR 820 & ISO13485.
- Knowledge of material in plastics, injection molding, and press-forming
- Demonstratable analytical skills, with experience in root cause analysis and structured problem-solving, including statistical analyses, DOE, etc.
- Excellent interpersonal and communication skills to collaborate effectively across multi-functional teams.
Preferred:
- 8+ years of experience in medical device manufacturing
- Experience with EU MDR submissions or approvals
- Advanced project management leadership experience
- Certification in Lean or Six Sigma methodologies
- Catheter experience is preferred
Skills & Competencies:
- Demonstrated experience with:
- Design controls
- Design Verification & Validation
- Design transfer activities
- Strong project management and organizational skills
- Experience working in a manufacturing environment
- Ability to work independently with minimal supervision
- Strong prioritization and workload management skills
- Excellent written and verbal communication skills
- Ability to write technical reports, business correspondence, and administrative procedures
Job Type: Full-time
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Flexible schedule
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Relocation assistance
- Retirement plan
- Vision insurance
Work Location: In person
