Top 2130 Manager Design For Manufacturability Jobs

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NPI Engineering Manager

AuST Manufacturing
West Valley City, UT

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Job Details

Full-time

Benefits

Health savings account
Relocation assistance
Health insurance
Dental insurance
401(k)
Paid time off
Vision insurance
401(k) matching
Flexible schedule
Life insurance
Retirement plan

Qualifications

New product introduction
Defect resolution root cause analysis
Engineering
Injection (injection molding)
Biomedical Engineering
Project management experience in manufacturing
Manufacturing facility experience
Statistical analysis
Six Sigma
Bachelor's degree
Medical device manufacturing facility experience
Continuous improvement
Quality control problem-solving
Quality standards in production
Biomedical regulatory compliance
Managing projects
Biomedical manufacturing processes
Root cause analysis
Regulatory compliance analysis
Analytical thinking
Lean manufacturing
ISO 13485
Cross-functional communication
FDA regulations

Full Job Description

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

Quick Apply

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