5 Sr. Design Assurance Engineer - Medical Device Jobs in Minneapolis, MN
SORT BY
A
N
C
R
i
Sr. Design Assurance Engineer - Medical Device
$165k-195k (estimate)
Full Time | Ancillary Healthcare
1 Week Ago
Resolution Medical is Hiring a Sr. Design Assurance Engineer - Medical Device Near Minneapolis, MN
DescriptionJob Summary:The Senior Design Assurance Engineer is a quality engineer that directly supports medical device product development from concept through commercialization working with cross-functional development teams to establish and maintain the design control deliverables, risk management activities, and DHF compliance to ensure delivery of the highest quality product to the customer.
Essential Functions
Essential Functions
- Create and ensure on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects and leading on-time completion of protocols, reports and assigned project deliverables
- Accountable for Design Verification and Validation planning and /or, including active cross-functional root-cause analysis investigation & resolution activities
- Lead Risk Management activities from product Concept through Commercialization
- Support design test and inspection method development, and lead method validation activities
- Ensure DHF content integrity, completeness, and regulatory / standards compliance; collaboratively communicating & resolving gaps
- Support and ensure internal & external audit responses and on-time product re-certifications
- Support and ensure the establishment of objective, measurable, discrete, and verifiable customer, and product requirements
- Support and ensure objective component specification definitions, supplied component sampling plan development, and vendor qualifications
- Provide support for biocompatibility and sterilization qualifications
- Develop and lead other team members and provide work direction as required
- May have 2-3 technicians assigned for inspection, testing and project support
- Performs other functions as required
- BS Industrial Engineering, Engineering or Business Degree
- 8-15 years of medical device experience in Quality Operations, or equivalent experience
- 1-3 years of supervisory experience preferred
- FDA regulations, ISO 13485, ISO 14971
- Statistical and data analysis
- Supervisory, Solid Management and Strong Leadership experience
- Prolonged periods sitting at a desk and working on a computer
- Must be able to lift 25 pounds at times
- Must have manual dexterity
- Must have excellent hand-eye coordination
- Must wear gown, gloves, and ear protection if applicable
Job Summary
JOB TYPE
Full Time
INDUSTRY
Ancillary Healthcare
SALARY
$165k-195k (estimate)
POST DATE
06/20/2024
EXPIRATION DATE
07/18/2024
WEBSITE
resolutionmedical.com
HEADQUARTERS
DANA POINT, CA
SIZE
50 - 100
FOUNDED
2012
TYPE
Private
CEO
REED R NOBLE
REVENUE
$5M - $10M
INDUSTRY
Ancillary Healthcare
Related Companies
About Resolution Medical
Resolution is a manufacturer and distributor of medical devices to healthcare sector.
Show more
Similar Jobs
Popular Articles
Top 10 Things to Avoid Putting on a Job Application
Read Article
How to Describe Your Education in a Resume
Read Article
How to Write a Memorable Cover Letter in 5 Ways
Read Article
4 Personal Finance Tips to Make During Job Transition
Read Article
4 Best Camera Setups for Interview
Read Article
Keeping a Job Search Journal: 9 Types of Journaling You Can Do
Read Article
