Integer Holdings Corporation · 4 weeks 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 embraces diversity and positions the company for long-term success. The Design Assurance Engineer II will participate in quality assurance activities for development projects, ensuring compliance with design and regulatory requirements, and supporting product development through various quality engineering tasks.
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
Generates and/or reviews related project deliverables, such as design verification and design validation protocols and reports; and process validation protocols and reports
Participates in risk assessment and mitigation activities (FMEA, FTA, etc.) in support of new product development
Supports Product Development Manufacturing Engineering in development of test fixtures/ test methodology, develop production acceptance criteria and test methods
Coordinates the preparation of Quality Plans, including inspection and gauge requirements
Provides support for root cause analyses, CAPA and Distributed Product Risk Assessment and updates SOPs as required
Coordinates sourced item qualification activities and supports supplier risk management initiatives
Performs other functions as required
Qualification
Required
Bachelor's degree in an engineering or related technical field
At least three 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)
Strong written and oral communication skills, including technical writing
Demonstrated ability to work in a team environment
Solid technical aptitude with the ability to be an effective contributor to a team or produce results of a technical nature as an individual
Functional understanding of the Integer Quality Management Systems
Ability to complete required Quality System documentation tasks with little or no direction from others
Demonstrated competency in both written and oral communications
Maintain a calm demeanor that transcends the high energy, constantly changing production environment
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