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Npi Manufacturing Engineer In Medical Device Jobs

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... NPI) and sustaining manufacturing operations within a regulated medical device environment. This ... Conduct supplier assessments in accordance with established risk-based procedures * Support ...

Our Operations team plays a critical role in bringing these innovations from concept to reality. We are seeking an NPI Manufacturing Engineer to join our Manufacturing Operations organization. This ...

Job Title: Manufacturing Engineer II Location: Saint Paul, MN Duration: 06+ Months Shift Timings ... Experience in medical device or regulated manufacturing environments * Exposure to line moves ...

MN · On-site

$63 - $67/hr

Medical device manufacturing experience (required). Previous experience supporting NPI, pilot ... in diagnostics, medical devices, nutritional and branded generic medicines. Working together ...

Manufacturing Engineer

Andover, MA · On-site

$55 - $93/hr

Need experience between 2 to 8+years in CNC and Manufacturing Systems / Tools * CNC programming * 4 ... Medical device manufacturing * High-compliance industrial manufacturing Benefits: * Health, dental ...

Manufacturing Engineer Here are the key skills highlighted in the below JD: Role Summary: The ... Experience in medical device or regulated manufacturing environment Exposure to cleanroom ...

Manufacturing Engineer

Andover, MA · On-site

$73K - $95K/yr

... strong experience in both sustaining engineering and new product introduction (NPI) within a ... Lead and support manufacturing engineering activities for electromechanical medical device ...

Manufacturing Engineer NPI

Denville, NJ

$72K - $93K/yr

In this highly visible, hands-on role, you work closely with design engineering, quality, supply ... Medical, Dental, and Vision Employee Stock Purchase Plan (ESPP) 401(k) with Company Match Holiday ...

Manufacturing Engineer We are seeking a Manufacturing Engineer with at least 2 years of experience ... Experience in a medical device manufacturing environment or other highly regulated industries.

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Npi Manufacturing Engineer In Medical Device information

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$47.5K

$85.6K

$120K

How much do npi manufacturing engineer in medical device jobs pay per year?

As of Jun 9, 2026, the average yearly pay for npi manufacturing engineer in medical device in the United States is $85,613.00, according to ZipRecruiter salary data. Most workers in this role earn between $73,000.00 and $94,000.00 per year, depending on experience, location, and employer.

What is the difference between Npi Manufacturing Engineer In Medical Device vs Quality Engineer In Medical Device?

AspectNpi Manufacturing Engineer In Medical DeviceQuality Engineer In Medical Device
Primary FocusDeveloping and implementing new manufacturing processes for medical devicesEnsuring product quality and compliance through testing and inspection
Key ResponsibilitiesDesign transfer, process validation, production ramp-upAudits, CAPA, risk management, regulatory compliance
Required CredentialsEngineering degree, knowledge of manufacturing processes, FDA regulationsEngineering or quality degree, knowledge of quality systems, FDA regulations
Work EnvironmentManufacturing floors, process development labsQuality labs, inspection areas, regulatory offices

While both roles require engineering knowledge and familiarity with FDA regulations, the Npi Manufacturing Engineer In Medical Device primarily focuses on developing and scaling manufacturing processes, whereas the Quality Engineer In Medical Device concentrates on maintaining product quality and compliance throughout production.

Infographic showing various Npi Manufacturing Engineer In Medical Device job openings in the United States as of June 2026, with employment types broken down into 1% Internship, 14% Full Time, 84% Part Time, and 1% Contract. Highlights an 87% Physical, 5% Hybrid, and 8% Remote job distribution, with an average salary of $85,613 per year, or $41.2 per hour.
Supplier Quality Engineer (SQE)

Supplier Quality Engineer (SQE)

Connexion Systems & Engineering, Inc.

Manchester, NH • On-site

$65K - $115K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 12 days ago

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Job description

Supplier Quality Engineer (2)

&

Sr. Supplier Quality Engineer (1)


Position Summary
The Supplier Quality Engineer (SQE) supports supplier quality activities across both New Product Introduction (NPI) and sustaining manufacturing operations within a regulated medical device environment. This role ensures supplier compliance to applicable requirements, including 21 CFR Part 820 and ISO 13485, and contributes to supplier qualification, development, monitoring, and performance management activities.
Supplier Qualification & NPI Support

  • Support supplier qualification activities for New Product Introduction (NPI) projects
  • Conduct supplier assessments in accordance with established risk-based procedures
  • Support supplier selection activities in collaboration with Engineering, Procurement, and Quality
  • Participate in supplier audits (remote and onsite) as part of qualification and surveillance activities
  • Review supplier documentation including certifications, quality records, and validation evidence
  • Support supplier readiness activities for production launch, including process and quality system evaluations
  • Participate in design transfer and process validation activities involving suppliers
  • Sustaining Supplier Quality Management
  • Support supplier quality oversight for assigned NPI projects and production suppliers
  • Monitor supplier performance using quality metrics (e.g., SCARs, defects, delivery performance)
  • Support supplier corrective action activities (SCAR/CAPA) and ensure timely closure
  • Conduct supplier performance reviews and drive continuous improvement initiatives
  • Support containment, root cause analysis, and resolution of supplier-related quality issues
  • Perform risk-based supplier re-evaluations and periodic assessments
  • Supplier Quality System & Compliance
  • Ensure supplier compliance with applicable regulatory and quality system requirements including ISO 13485
  • Maintain and improve Approved Supplier List (ASL) classification and risk-based controls
  • Support external and internal audits involving supplier quality systems
  • Ensure supplier quality agreements are established and maintained
  • Drive adherence to change notification and supplier control requirements
  • Cross-Functional Collaboration
  • Partner with Design Authority (customer), Procurement, Manufacturing and Engineering
  • Support material nonconformance investigations and disposition decisions
  • Provide supplier risk input to project teams and change control processes
  • Support supply continuity and risk mitigation strategies

Qualifications

  • Bachelor’s degree in Engineering, Life Sciences, or related technical field; or equivalent experience in regulated industry may be considered in lieu of degree.  
  • 1-3 years of experience in Supplier Quality, Quality Engineering, or related role in medical device or regulated industry
  • Strong knowledge of ISO 13485 and medical device regulatory requirements
  • Understanding of quality systems and regulatory expectations (21 CFR Part 820, ISO 13485)
  • Exposure to supplier quality, manufacturing, or inspection processes preferred
  • Experience supporting NPI, manufacturing, or engineering projects a plus

Preferred Certifications

  • ISO 13485 Internal Auditor certification (or willingness to obtain). 
  • ASQ certifications (CQE, CQA, or similar) are a plus.