Medix™
Senior Quality Engineer - Medical Device R&D - Job ID: 248569
Medix™, Minneapolis, Minnesota, United States, 55400
Senior Quality Engineer – Drive Innovation in Catheter Manufacturing (Twin Cities, MN)
Are you a
Quality Engineer
with a passion for bringing cutting-edge medical devices from prototype to production? Do you thrive in an environment where your expertise in
validation
and
statistical analysis
directly impacts product success?
Our client, a leading
Catheter CDMO
in the Twin Cities, is seeking a Senior Quality Engineer to be the onsite quality anchor within their dynamic R&D/Prototype Center. This role is perfect for an independent, customer-facing engineer ready to own the quality framework for next-generation catheter technologies.
The Opportunity: Engineering Quality for the Future This is an exciting, highly autonomous role focused on the upstream quality engineering required for new product introduction (NPI). You will be the primary quality contact, working hand-in-hand with development engineers and customers as products move through the R&D pipeline.
Process & Test Method Validation:
Spearhead and contribute to qualification and validation activities (IQ/OQ/PQ) required for manufacturing process release and transfer, with a strong emphasis on
Test Method Validation .
Statistical Analysis Expert:
Apply your deep knowledge of statistical tools, including
Gage R&R ,
Root Cause Analysis (RCA) , and
Statistical Process Control (SPC)
(e.g., Minitab), to ensure process capability and reliability.
Customer-Facing Partner:
Act as a technical quality liaison, primarily via email, to external customers during the prototyping and development phase.
QMS & Compliance Champion:
Promote and uphold strong
GMP, GDP, and QMS
principles, contributing to internal audit effectiveness.
Independent Leadership:
As the sole QE onsite, you will manage the site’s quality engineering needs and direct the work of two inspectors. Your manager provides remote support and rotates between the three sites.
What You'll Bring (Must-Have Qualifications)
5+ Years
of Quality Engineering experience within the
medical device manufacturing industry
(ISO/FDA regulated environment).
Proven expertise in
Process Validation and Test Method Validation .
Strong command of
Statistical Analysis
techniques (Gage R&R, RCA, SPC).
Demonstrated
customer-facing
communication skills, comfortable supporting development teams and external partners.
Ability to work
independently
and manage the quality function on-site with minimal direct supervision.
Nice-to-Have Skills
Previous experience with
Class II or Class III
medical devices.
Direct experience with
catheter or shaft
manufacturing/extrusion.
Background working within a
CDMO
or small OEM environment.
Compensation & Benefits Highlights
Competitive starting salary
up to $115K
based on experience. Eligibility for an
8% annual bonus .
Great Work-Life Balance:
Enjoy a
4.5-day work week
(M-Th, 9-hour days; F, 4-hour shift).
Location & Travel This role is primarily based at the
New Hope, MN
facility. Occasional, limited travel will be required to our sister sites in Maplewood and potentially Cokato.
If you are ready for a challenging and rewarding role where you can truly influence the quality foundation of innovative medical devices,
Apply Today!
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance
Industries
Medical Equipment Manufacturing
#J-18808-Ljbffr
Quality Engineer
with a passion for bringing cutting-edge medical devices from prototype to production? Do you thrive in an environment where your expertise in
validation
and
statistical analysis
directly impacts product success?
Our client, a leading
Catheter CDMO
in the Twin Cities, is seeking a Senior Quality Engineer to be the onsite quality anchor within their dynamic R&D/Prototype Center. This role is perfect for an independent, customer-facing engineer ready to own the quality framework for next-generation catheter technologies.
The Opportunity: Engineering Quality for the Future This is an exciting, highly autonomous role focused on the upstream quality engineering required for new product introduction (NPI). You will be the primary quality contact, working hand-in-hand with development engineers and customers as products move through the R&D pipeline.
Process & Test Method Validation:
Spearhead and contribute to qualification and validation activities (IQ/OQ/PQ) required for manufacturing process release and transfer, with a strong emphasis on
Test Method Validation .
Statistical Analysis Expert:
Apply your deep knowledge of statistical tools, including
Gage R&R ,
Root Cause Analysis (RCA) , and
Statistical Process Control (SPC)
(e.g., Minitab), to ensure process capability and reliability.
Customer-Facing Partner:
Act as a technical quality liaison, primarily via email, to external customers during the prototyping and development phase.
QMS & Compliance Champion:
Promote and uphold strong
GMP, GDP, and QMS
principles, contributing to internal audit effectiveness.
Independent Leadership:
As the sole QE onsite, you will manage the site’s quality engineering needs and direct the work of two inspectors. Your manager provides remote support and rotates between the three sites.
What You'll Bring (Must-Have Qualifications)
5+ Years
of Quality Engineering experience within the
medical device manufacturing industry
(ISO/FDA regulated environment).
Proven expertise in
Process Validation and Test Method Validation .
Strong command of
Statistical Analysis
techniques (Gage R&R, RCA, SPC).
Demonstrated
customer-facing
communication skills, comfortable supporting development teams and external partners.
Ability to work
independently
and manage the quality function on-site with minimal direct supervision.
Nice-to-Have Skills
Previous experience with
Class II or Class III
medical devices.
Direct experience with
catheter or shaft
manufacturing/extrusion.
Background working within a
CDMO
or small OEM environment.
Compensation & Benefits Highlights
Competitive starting salary
up to $115K
based on experience. Eligibility for an
8% annual bonus .
Great Work-Life Balance:
Enjoy a
4.5-day work week
(M-Th, 9-hour days; F, 4-hour shift).
Location & Travel This role is primarily based at the
New Hope, MN
facility. Occasional, limited travel will be required to our sister sites in Maplewood and potentially Cokato.
If you are ready for a challenging and rewarding role where you can truly influence the quality foundation of innovative medical devices,
Apply Today!
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance
Industries
Medical Equipment Manufacturing
#J-18808-Ljbffr