Lead Design Quality Engineer - Surgical Device - Billerica MA

Billerica Permanent USD100,000 - USD115,000 per year
  • Growing Medical Device Startup with commercially accessible products in the US
  • Work closely with the Director of Quality Assurance on a completely hybrid basis

About Our Client

Our client spent many hours shadowing physicians to learn about the struggles of vascular access during procedures. After trial and error, our client developed and perfected their patent approved, unique-to-market catheter offering the least intrusive option for vascular visual access. With two products on the market and more on the way, our client is growing and looking to make additions to the team to match this financial growth.

Job Description

The Lead Design Quality Engineer will:

  • Provide Quality Engineering support for New Product Development, Manufacturing, and other Supply Chain functions throughout all phases of Design Controls
  • This is a collaborative position working closely with R&D, Manufacturing, Sales & Marketing, and others to ensure a constant state of control and compliance for QMS, and FDA QSR requirements
  • Serve as Quality Engineer on New Product Development teams, leading Risk Management activities, collaborating on V&V and Design Transfer activities
  • Identify and implement effective process control systems to support product manufacturing, and new product development initiatives
  • Manage and administer the Nonconforming Product, CAPA, and Complaint Handling processes
  • Lead or participate in product / process improvement efforts utilizing methodical problem-solving approaches

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

The Successful Applicant

The Lead Design Quality Engineer should have:

  • Bachelors of Science
  • 5+ years hands on medical device manufacturing experience
  • Working knowledge of 21 CFR 820 and ISO 13485:2016 is a must
  • Working knowledge of data analysis methods, including basic statistics, preferably using Minitab or other similar data analysis software
  • Critical reasoning and excellent data presentation skills
  • Self-initiator with strong organization skills

What's on Offer

Our client can offer in return:

  • Competitive base salary and benefits
  • Bonus Structure
  • Hybrid Work Model
  • Work closely with the Director of Quality Assurance

Please reach out to Cameron Cyker with questions, and apply today!

Cameron Cyker
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Job summary

Engineering & Manufacturing
Sub Sector
Six Sigma, Lean, Process improvement
Industrial / Manufacturing
Contract Type
Consultant name
Cameron Cyker
Job Reference