Design Assurance Engineer III
Integer Holdings Corporation
- # Design Assurance Engineer IIIApplylocations: Plymouth, MNtime type: Full timeposted on: Posted Todayjob requisition id: R35567By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success.At Integer, our values are embedded in everything we do.**Customer**We focus on our customers’ success**Innovation**We create better solutions**Collaboration**We create success together**Inclusion**We always interact with others respectfully**Candor**We are open and honest with one another**Integrity**We do the right things and do things rightLake Region Medical, Inc. dba Integer Holdings Corporation seeks Design Assurance Engineer III in Plymouth, MN.Duties: Adheres to Integer values 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. 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. Builds consensus where appropriate. Leads Risk Management (ISO 14971) activities. May lead cross functional teams in planning, analyses (DFMEA, FTA, Risk/Benefit) and mitigations. Maintains risk management file for the life of the device. Generates and/or reviews related project deliverables such as: design verification and design validation protocols and reports as well as process validation protocols and reports. Coordinates with R&D in the review of technical documentation. Works with Product Development Manufacturing Engineering in the development of test fixtures, develop production acceptance criteria and test methodology. Coordinates 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. Provides support in conducting root cause analyses, preparation of CAPA and Distributed Product Risk Assessment. Draft and update SOPs as required.Requires a Bachelor’s degree in Mechanical Engineering or related field plus 5 years’ experience. Alternatively, employer will accept a Master’s degree in Mechanical Engineering or a related field plus 3 years' of experience. Requires 5 years of experience (or 3 years with Master’s) in the following: Use of Quality lean sigma tools (Root Cause Analysis, QFD, Ishikawa, Kepner Tregoe); Performing Gage Repeatability and Reliability studies and Attribute Agreement Analysis for test method validation; performing sourced item qualification (sourced component and supplier qualification); and investigating non-conforming material, review and dispositions including review of schematics, drawings and design specifications. Requires 4 years of experience (or 2 years with Master’s) in the following: Creating risk management files per ISO 14971 for Class 2 or 3 devices for EU Medical Device Regulation (EU MDR 2017) or 510K FDA submissions; and Performing Design Verification and Validation (creating protocols, executing testing and creating reports) for Class 2 or 3 devices for EU Medical Device Regulation (EU MDR 2017) or 510K FDA submissions.40 hours/week. Benefits discussed at interview. Must also have authority to work permanently in the U.S. Applicants who are interested in this position may apply Ref # 14057.**INTEGER encourages Associates to be a part of the Talent Acquisition process and promote our values, behaviors and a commitment to a diverse workforce through qualified Associate referrals. Please review the Associate Referral Guidelines for information on process and bonus eligibility.**Microsoft Word Integer Associate Referral Guidelines - revised 11-22-20 (sharepoint.com)Our total rewards program is designed to attract, retain, and motivate associates to contribute to Integer’s success. Our compensation program includes base salary and a cash-based incentive program supporting our pay-for-performance philosophy. We provide a comprehensive benefits package with immediate eligibility including medical, dental, vision, disability, life insurance, and adoption benefits. Parental leave is available after one year. Optional employee-paid programs include supplemental life insurance, critical illness, hospital indemnity and accident insurance. Employees are immediately eligible to participate in the 401(k) plan with company matching contributions. We provide 80 hours (10 days) of company designated holidays per year plus an annual allotment of paid time off.**U.S. Applicants: Equal Opportunity Employer. In addition, veterans and individuals with disabilities are encouraged to apply.**### About UsInteger 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. As a strategic partner of choice to medical device companies and OEMs, Integer is committed to enhancing the lives of patients worldwide by providing innovative, high-quality products and solutions. The company's brands include Greatbatch Medical and Lake Region Medical. Additional information is available at Holdings Corporation (“Integer”) is an equal opportunity employer. We do not discriminate based on race, color, sex, religion, national origin, and on any other protected characteristics. We celebrate our many differences and remain committed to providing an inclusive workplace free from harassment and discrimination.Integer does not discriminate against any applicants or employees because he or she is a disabled veteran, Armed Forces service medal veteran, recently separated veteran, or active-duty wartime veteran, campaign badge veteran, referred to collectively as "Protected Veterans." It is also the policy of Integer to employ and to advance in employment, all people regardless of their status as individuals with disabilities. All employment decisions are based only on valid job requirements. This policy shall apply to all employment actions, including but not limited to recruitment, hiring, promotion, transfer, demotion, layoff, recall, termination, rates of pay or other forms of compensation, and selection for training, including apprenticeship, at all levels of employment.Additionally, Integer provides reasonable accommodations to qualified job applicants and associates who need them for medical or religious reasons. If you are interested in applying for an employment opportunity with Integer and believe you will need an accommodation for the application or job interview processes, please contact us at +716-759-5631 or via View email address on click.appcast.io so that we may discuss appropriate adjustments to our processes to enable you to be considered for a job opening. This phone number and email address is strictly for the purpose of making a request for an accommodation. Status updates on your application cannot be provided to you through this phone extension or email. For status updates, please log in to
- J-18808-Ljbffr Integer Holdings Corporation
Vacancy posted 7 hours ago
Similar jobs that could be interesting for youBased on the Design Assurance Engineer III in Minneapolis, MN vacancy
$78.3k
...Design Assurance Engineer III At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest...SuggestedWork at officeRelocation package3 days per weekIntracept by Boston Scientific
Saint Paul, MN4 days ago$78.3k
...advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions. About the role: The Design Assurance Engineer III directly supports medical device product development from concept through commercialization. This engineer will serve as...SuggestedHourly payWork at officeRelocation packageShift work3 days per week$85k
...Forbes as one of the Best Workplaces for Engineers in 2026, reflecting a culture where... ...employees experience every day. The Senior Design Assurance Engineer will directly support medical... .... Proven experience with Class III medical devices, including Electrical Medical...SuggestedHourly payRelocationRelocation packageShift workBoston Scientific
Arden Hills, MN1 day ago$85k
...and career. Here, you'll be supported in progressing - whatever your ambitions. About the role: This Senior Design Assurance Engineer will work on the Axonics Integration project, specifically supporting product Design Control integration under the direction...SuggestedHourly payWork at officeLocal areaRemote workRelocation packageShift work3 days per weekBoston Scientific
Minnetonka, MN3 days ago- ...Senior Design Assurance Engineer Veranex's mission as an Innovation CRO is to improve patient outcomes by accelerating our clients' innovations to market. As the world's only end-to-end professional services firm focused on MedTech, we take clients' Vision to Velocity...SuggestedWork experience placement
Veranex
Minneapolis, MN3 days ago $100k - $130k
...A medical device manufacturing client is looking to hire a Senior Design Assurance Engineer in Maple Grove. This person will be responsible for design of quality input and deliverables for new product development programs. This person will] support sustaining activities...Contract workCypress HCM
Maple Grove, MN2 days ago- ...We’re looking for a Senior Design Assurance Engineer in Maple Grove, MN to support innovative medical device development. You’ll lead design assurance activities, ensure compliance with regulatory standards, and collaborate with cross-functional teams to bring safe...
JCW Group
Minneapolis, MN3 days ago $91.35k - $146.16k
Staff Design Assurance Engineer page is loaded## Staff Design Assurance Engineerlocations: Plymouthtime type: Full timeposted on: Posted Todayjob requisition id: 564752### Job TitleStaff Design Assurance Engineer### Job DescriptionThe Staff Design Assurance Engineer will...Full timeWork at officeImmediate startWork visaRelocation package3 days per week$110k - $160k
...patients, providers, and carepartners to establish a better way forward in stroke care. About the role The Principal Design Assurance Engineer supports product design and development activities and ensures the effective transfer of new products into manufacturing....Work at officeLocal areaMobia Medical, Inc.
Fridley, MN2 days ago$61.3k - $122.7k
...health and get on with their lives. As an Engineer II, you will be providing development... ...throughout concept to launch in all phases of Design Production/Process Controls with a focus... ...as FDA and ISO as it relates to design assurance. Support and ensure the establishment of...Full timeFor contractorsWorldwideShift work$90.4k - $147.4k
...one of America's Best-In-State Employers 2025! NPI Quality Assurance Engineer III Make your mark at the world's largest HVAC company... ...Introduction Process (NPI). This requires partnering with the product design team, supplier quality & factory quality assurance...Work at officeLocal areaOverseasDaikin Applied
Minneapolis, MN2 days ago$85k - $161.5k
Boston Scientific Gruppe is seeking a Senior Design Assurance Engineer for the Axonics Integration project in Minnetonka, MN. This role involves ensuring high-quality product design compliance and assisting in integration processes. Candidates should have a Bachelor's degree...Relocation package$87.4k - $103.74k
Product Lifecycle Engineer III - Plymouth, MN March 20, 2026 Salary Range: $87,400.00 To $103,740.00 Annually What You Will Do The Product... ...FFF) evaluations, manufacturing process improvements, product design optimizations, and initiatives that improve operational...Flexible hours- ...Job Role : Senior Design Assurance Engineer — Medical Device (Onsite — Arbor Lakes , MN ) Contract Overview: From development... ...Preferred Qualifications: Experience with class III medical devices BS in Electrical Engineering Previous...Contract work
$95k - $104k
...member of the Bracco Medical Technologies team has the power to make a difference every day. As part of the Quality Assurance team, the Design Assurance Engineer II - Software position will support design assurance activities for BMT products. Primary Duties &...Temporary workCasual workWork at officeWorldwideFlexible hours- Acist Medical Systems Inc. is seeking a Design Assurance Engineer II - Software to support design assurance activities for BMT products. This role involves leading the Design Control process, assessing testing protocols, and collaborating with external organizations to...
- A leading automation solutions provider in Plymouth, MN is seeking a Product Lifecycle Engineer III. This role involves supporting active products throughout their lifecycle, focusing on operational efficiency, product quality improvement, and cross-functional teamwork...
- A leading medical technology company is seeking a Software Design Assurance Engineer II based in Eden Prairie, Minnesota. This role involves supporting design assurance activities for medical devices, ensuring compliance with regulatory standards, and leading risk management...
- ...Job Description Job Description Design Assurance engineer to represent the Quality function on a product development team. This engineer would be a key contributor to risk management and design verification planning and execution. Secondarily, this position would also...
$88.8k - $152.3k
Tech Product Owner III - Quality Engineering and Test Automation Job Category: Information Technology Requisition Number: TECHP006012 Contract Type: Full-Time Location: Office required. Onsite, average three days per week. Candidate must be near Minnetonka MN, Madison...Full timeContract workWork experience placementWork at office3 days per week$78.3k
...looking for a highly motivated Process Engineer III - Battery Chemist to join our fast-growing... ...cross-functional collaboration to design and commercialize advanced technology, supporting... ...Company will continue to take steps to assure that recruitment, hiring, assignment,...Hourly payWork at officeLocal areaRelocation packageShift work- ...usability validation testing (including authorship of protocol, study design, study execution, data analysis, and report writing)... ...Bachelor’s Product line this person will support: Class III, implantable neurostimulator and associated components Years...Remote workWork from home1 day per week
Lancesoft INC
Minneapolis, MN27 days ago $98.8k - $167.1k
...Job Description Engineer III or IV - Storage SUMMARY Mortenson is currently... ...assignments by supporting Engineer of Record design packages and construction support for... ...data to recommend courses of action. Assure proper documentation of technical data...Work experience placementH1bWork at officeM. A. Mortenson
Minneapolis, MN1 day ago- ...Tool And Die Maker III Exceptional People. Hard Problems. Meaningful Careers. Big Impact. Nowhere else can you touch... ..., troubleshoots complex tools, and works closely with engineering on tooling issues and design improvements. Job Duties & Responsibilities: #...Local area
$98.18k - $109.73k
Manufacturing Engineer III - Plymouth, MN December 1, 2025 Manufacturing Engineer III: Drive Process Excellence & Innovation Salary Range... .... Continuous Improvement & Lean Leadership: Research, design, and develop manufacturing process improvements (production flow...Temporary workWork experience placementFlexible hours$81.18k - $109.73k
Manufacturing Engineer II or III - Plymouth, MN May 1, 2025 Salary Range :$81,175.00 To $109,725.00 Annually Overview Turck has a reputation... ...assigned products, processes and equipment Perform research, design and development/improvement of manufacturing processes including...Work experience placement$104k - $156k
...connected, compassionate world. A Day in the Life Senior Design Automation Engineer Careers that Change Lives At Medtronic you can begin... ...that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required. Physical Job Requirements The...Work experience placementH1bWork at officeLocal areaWorldwideFlexible hoursMedtronic
Minneapolis, MN3 days ago- ...one of America's Best-In-State Employers 2025! HVAC Test Engineer III - Plymouth, MN - Onsite Make your mark at the world's largest... ..., heat transfer, thermodynamics, fluid mechanics, machine design, and strength of materials Excellent verbal and written communication...Interim roleWork at officeLocal area
Daikin Applied
Plymouth, MN16 hours ago $132.23k - $176.31k
...building the future. The Role SAIC seeks a Lumen Network Design Engineer V (WAN / Work Package Engineer) to support the Department of... ...required. ~ Active TS/SCI or SCI Eligible. ~ IAT Level I/II/III Certification. ~ Travel is required ~ Education/experience...Contract workTemporary workFor contractorsRemote workLumen Inc
Saint Paul, MN1 day ago- A manufacturing solutions provider is looking for a Manufacturing Engineer III in Plymouth, MN. This role focuses on process ownership, efficiency improvements, and mentoring within a collaborative environment. Candidates should have a BS in Engineering and over 5 years...
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Design Assurance Engineer III. Be the first to apply!
Related searches
- data center design engineer Minneapolis, MN
- senior design verification engineer Minneapolis, MN
- physical design engineer Minneapolis, MN
- sr. product engineer Minneapolis, MN
- product engineer Minneapolis, MN
- product design engineer Minneapolis, MN
- new product engineer Minneapolis, MN
- senior product design engineer Minneapolis, MN
- senior fpga design engineer Minneapolis, MN
- senior manager product engineering Minneapolis, MN