Risk Management Quality Engineer I, New Product Development (Surgical)

Medtronic

Confirmed live yesterday High trust
Closes in 4 days Hybrid

Quick summary

Work type
Hybrid
Location
North Haven, CTBoston, MALafayette, CO
Salary
$66,400–$99,600 / yr
Posted
3 days ago
Freshness
Confirmed live yesterday
Closes
Sep 22, 2026 (soon)

Market check

Salary context

Below market

How this pay compares to similar roles

Similar $162k
This role $83k
$51k most similar roles pay here $208k

This role pays less than 99% of similar roles. Most pay $130,882–$193,250 — the shaded band above. At the midpoint, this role pays about $83k versus about $162k for comparable roles.

Based on 240 similar postings.

Employer

About Medtronic

Medtronic plc is the world's largest medical technology company by revenue, specializing in device-based therapies for over 70 health conditions.

Medtronic currently has 48 open roles on FindRole.

Listed pay typically runs $128,800–$193,200 across 47 roles with salary data.

Most-posted roles

View all roles at Medtronic

At a glance

TL;DR · Risk Management Quality Engineer I, New Product Development (Surgical)

Risk Management Quality Engineer I - New Product Development (Surgical) joins the surgical operating unit within the new product development quality team to ensure patient safety is embedded throughout the medical device lifecycle. This role involves developing and maintaining risk management files, conducting hazard and risk analysis, leading Design Failure Modes and Effects Analyses (DFMEAs), and managing post-market surveillance plans. The position requires ensuring compliance with regulatory standards such as FDA, ISO 14971, 13485, and 62304 while overseeing design verification and validation activities. Key responsibilities include analyzing product complaints, integrating security measures, and maintaining traceability between risk files and requirements using a requirements management tool. The ideal candidate possesses a bachelor’s degree in engineering or a related field and utilizes skills in Minitab, Microsoft Office, and potentially Design for Six Sigma or Design for Reliability methodologies.

What you'll do

  • Create and maintain risk management files, including plans, reports, and regular risk reviews.
  • Lead hazard and risk analysis activities to identify risks and implement control measures.
  • Lead Design Failure Modes and Effects Analyses (DFMEAs) with project teams to evaluate potential failures.
  • Analyze product complaints to anticipate and prevent future issues.
  • Integrate product security measures into the risk management file to protect against vulnerabilities.
  • Develop and manage post-market surveillance plans to monitor field performance and safety.
  • Lead field issue evaluations, including root cause analysis and containment strategies during initial launch.
  • Ensure traceability between risk management files, requirements, and design outputs using tracking tools.

What we're looking for

  • Bachelor's degree in engineering or a related technical field.
  • Candidates must possess unrestricted U.S. work authorization at the time of hire.
  • Experience in medical devices, pharmaceuticals, or combination products (preferred).
  • Familiarity with medical device risk management standards such as ISO 14971 (preferred).
  • Background in Quality Engineering, Risk Management, R&D, Systems Engineering, or similar roles (preferred).
  • Experience in New Product Development environments (preferred).
  • Certification or experience with Design for Six Sigma or Design for Reliability methodologies (preferred).
  • Certified Quality Engineer, Six Sigma Green Belt, or AAMI design control certification (preferred).

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