Integer Holdings Corporation · 6 days ago
Design Assurance Engineer II- Chaska
Chaska, MN
Full-time
Onsite
Mid Level
$79K/yr - $116K/yr
3+ years expInteger Holdings Corporation is committed to creating a culture that values customer success, innovation, collaboration, inclusion, candor, and integrity. The Design Assurance Engineer II will participate in development project teams, ensuring compliance with quality and regulatory requirements while generating and executing validation protocols for design verification test methods.
Health CareManufacturingMedicalMedical Device
Responsibilities
You adhere to Integer’s Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements
As a quality Core Team member, actively participates in development project teams. Performs quality/reliability engineering activities to ensure that the design/development procedures, design controls, supplier controls and test requirements are fulfilled
Responsible to generate and execute validation protocols and reports (IEQ,PQ, TMV, SWIQ) for design verification test methods
Support DA lab staff during design verification and design validation protocols execution (test)
Collaborates with DA, R&D, and NPI teams to develop, validate, and implement test methods. Leads efforts in fixture design, test method qualification, and creation of clear, accurate work instructions
Drive and support continuous improvement initiatives for legacy test methods
Provides support for root cause analyses, CAPA and Distributed Product Risk Assessment and updates SOPs as required
Initiates, reviews, and approves engineering change requests and documentation
Performs other functions as required
Qualification
Required
You earned, as a minimum, a bachelor's degree in an engineering or related technical field; and have at least three years of relevant experience
Candidates who do not meet the education requirement may be considered with 7+ years of relevant experience
Experience with statistical software packages such as Minitab
Demonstrated problem solving skills
Knowledge of ISO and FDA quality, process validation and system requirements
Experience in interpreting design schematics and drawings
Skilled in statistical methods e.g. ANOVA, SPC, sample size determination, Gauge R&R and DOE
Knowledge of quality lean sigma tools (e.g. Root Cause Analysis, QFD, Ishikawa, Kepner-Tregoe)
Experience with Lab Measurement equipment (Microscope, Caliper, Multimeter, Tensile tester, Vision Systems, etc)
Knowledge of mechanical and electrical test methods (Tensile, 3-point bend, coating performance, torqueability, trackability, fatigue tip stiffness, leak test, continuity, resistance, particulate. Etc)
Solid works experience
Strong written and oral communication skills, including technical writing
Demonstrated ability to work in a team environment
You demonstrate a solid technical aptitude with the ability to be an effective contributor to a team or produce results of a technical nature as an individual
You have a functional understanding of the Integer Quality Management Systems and are able to complete required Quality System documentation tasks with little or no direction from others
You demonstrate competency in both written and oral communications
You maintain a calm demeanor that transcends the high energy, constantly changing production environment
You possess a positive, can-do attitude with an underlying belief that failure is not an option
Benefits
Medical
Dental
Vision
Disability
Life insurance
Adoption benefits
Parental leave
Supplemental life insurance
Critical illness
Hospital indemnity
Accident insurance
401(k) plan with company matching contributions
80 hours (10 days) of company designated holidays per year
Annual allotment of paid time off
Company
Integer Holdings Corporation
Integer Holdings Corporation (NYSE: ITGR) is one of the largest medical device contract development and manufacturing organizations (CDMO) in the world, serving the cardiac rhythm management, neuromodulation, and cardio and vascular markets.
10001+ employees
H1B Sponsorship
Integer Holdings Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (3)
Funding
Current Stage
Public CompanyTotal Funding
$1.44BKey Investors
Disruptive Technologies Innovation Fund
2025-09-25Grant
2025-03-13Post Ipo Debt· $1B
2023-01-31Post Ipo Debt· $435M
Leadership Team
Payman Khales
President and CEO
Recent News
Company data provided by crunchbase