Integer Holdings Corporation · 3 months ago
Senior Design Assurance Engineer (Chaska)
Chaska, MN
Full-time
Onsite
Senior Level
$122K/yr - $179K/yr
7+ years expInteger Holdings Corporation is committed to a culture that values customer success, innovation, collaboration, inclusion, candor, and integrity. They are seeking a Senior Design Assurance Engineer who will play a key role in development project teams, ensuring that design and development procedures meet safety and quality requirements, while leading risk management and usability program activities.
Health CareManufacturingMedicalMedical Device
Responsibilities
Adheres to Integ Core Beliefs and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements
As a quality Core Team member, plays a key role on development project teams. Performs quality/reliability engineering activities while providing guidance and expert advice to ensure that the design/development procedures, design controls, supplier controls and test requirements are fulfilled
Leads Risk Management (ISO 14971) and Usability program activities. Leads cross function teams in planning, analyses (DFMEA, FTA, Risk/Benefit) and mitigations. Maintains risk management file for the life of the device
Generates and/or reviews and provides guidance for related project deliverables, such as design verification and design validation protocols and reports as well as process validation protocols and reports. Works cross functionally with R&D and provides expert guidance in the review of technical documentation
Leads and provides guidance with Product Development Manufacturing Engineering in development of test, develop production acceptance criteria, test methods, and process validation protocols
Leads and provides guidance for sourced item qualification activities and supports supplier risk management initiatives. Conducts Independent review of DHF and Technical files, provides technical standards interpretation, and determines appropriate statistical methods, including sample size determination. Is the SME for standards interpretation and statistical methods
Leads and provide guidance for root cause analyses investigations, preparation of CAPA and Distributed Product Risk Assessment. Draft and update SOPs as required
Performs other functions as required
Qualification
Required
Bachelor's Degree in Engineering or related field required
7-10 years of experience
Practical knowledge of FDA Quality System Regulations, ISO 13485 and Medical Device Directive
Practical knowledge of ISO 14971 and related standards
General familiarity with industry best practices in development, testing and manufacturing processes
Medical device sterilization process
Experience in interpreting design schematics and design drawings
Demonstrated proficiency in statistical methods e.g. ANOVA, SPC, test sample size plans, Gauge R&R, and DOE
Demonstrated proficiency utilizing quality lean sigma tools (e.g. Root Cause Analysis, QFD, Ishikawa, Kepner-Tregoe)
Proficient in establishing and implementing quality metrics for product development
Strong collaboration, negotiation, and conflict resolution skills
Ability to lead team activities and coach
Excellent communication, presentation, follow through and organizational skills, verbal and written communication skills to be applied at all levels of the organization
Excellent technical writing skill
Preferred
Master's Degree preferred
Preferred experience with FDA and European regulated medical devices
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