Talent.com
Design Assurance Engineer III (Chaska)
Design Assurance Engineer III (Chaska)Integer Holdings Corporation • Chaska, MN, United States
No longer accepting applications
Design Assurance Engineer III (Chaska)

Design Assurance Engineer III (Chaska)

Integer Holdings Corporation • Chaska, MN, United States
16 days ago
Job type
  • Full-time
Job description

By 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 right

Adheres to Integer 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.

Job Requirements

Minimum Education : Bachelor's Degree in Engineering or related field required. Master's Degree preferred.

Minimum Experience : 7-10 years of experience.

Specialized Knowledge :

  • 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.
  • Preferred experience with FDA and European regulated medical devices
  • 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.
  • Special Skills :

  • 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
  • May travel up to 10% .
  • Salary Range : $97,350-$142,780
  • 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.

    Create a job alert for this search

    Design Engineer Iii • Chaska, MN, United States

    Related jobs
    Senior Design Assurance Engineer

    Senior Design Assurance Engineer

    JCW Group • Minneapolis, MN, United States
    Full-time
    Senior Design Assurance Engineer.You’ll lead design assurance activities, ensure compliance with regulatory standards, and collaborate with cross-functional teams to bring safe, high-quality produc...Show more
    Last updated: 15 days ago • Promoted
    Quality Engineer - Design Assurance

    Quality Engineer - Design Assurance

    JCW Group • Minneapolis, MN, United States
    Full-time
    In this role, you’ll lead design assurance activities, support new product development, and ensure compliance with regulatory standards. Lead design assurance activities, including verification, val...Show more
    Last updated: 15 days ago • Promoted
    Design Engineer

    Design Engineer

    Apex Engineering Group • Minnetonka, MN, US
    Full-time
    Quick Apply
    Any Apex Office (Fargo, Bismarck, or Dickinson, ND or Detroit Lakes, St.Cloud, or Minnetonka, MN) Apex Engineering Group has openings for a Design Engineer working in the Transportation Group...Show more
    Last updated: 30+ days ago
    Reserve Entomologist

    Reserve Entomologist

    United States Army • Winsted, MN, United States
    Full-time
    THE ARMY HEALTH CARE ADVANTAGE As a member of the Army health care team, you’ll receive benefits that you won’t be able to get in a civilian career. Challenging Work Feel inspired with great case di...Show more
    Last updated: 13 days ago • Promoted
    Dietitian

    Dietitian

    United States Army • Lester Prairie, MN, United States
    Permanent
    Army Dietitians provide the tools for health living for Soldiers and their families.If you are a professional in the dietetic field and want to combine your knowledge and passion for living a healt...Show more
    Last updated: 30+ days ago • Promoted
    Diesel Technician

    Diesel Technician

    Love's Travel Stops • Montrose, MN, US
    Full-time
    Fuel Your Growth with Love's - company funded tuition assistance program.Paid Time Off • Flexible Scheduling • 401(k) – 100% match up to 5% • Medical / Dental / Vision Insurance after 30 days • Competi...Show more
    Last updated: 1 hour ago • Promoted • New!
    Plant Manager

    Plant Manager

    Data Metalcraft Inc. • Arlington, MN, US
    Full-time
    With an emphasis on emerging technologies, engineering expertise, and quality, our highly qualified team delivers complete solutions to complex fabrication programs. We are seeking a highly skilled ...Show more
    Last updated: 30+ days ago • Promoted
    Senior Design Assurance Engineer (Chaska)

    Senior Design Assurance Engineer (Chaska)

    Integer Holdings • Chaska, MN, United States
    Full-time
    By 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 val...Show more
    Last updated: 1 day ago • Promoted
    Senior Design Assurance Engineer

    Senior Design Assurance Engineer

    Imricor Medical Systems Inc • Burnsville, MN, US
    Full-time
    Must be able to work at Burnsville Location.The expected salary for this Minnesota-based position is between $105,000-130,000. This range represents a good faith estimate for this position.The speci...Show more
    Last updated: 21 days ago • Promoted
    Senior Design Assurance Engineer

    Senior Design Assurance Engineer

    Nextern • Maple Grove, MN, US
    Full-time
    Quick Apply
    Nextern is looking for a talented.Senior Design Assurance Engineer.This role involves ensuring that our product designs meet rigorous quality and safety standards throughout the development process...Show more
    Last updated: 30+ days ago
    Product Design Engineer II - Located in Warroad, MN

    Product Design Engineer II - Located in Warroad, MN

    Marvin • Minneapolis, MN, United States
    Full-time
    Design Engineer II is responsible for product design activities including developing innovative designs and / or improving upon the performance and design of existing products.Will perform moderately...Show more
    Last updated: 11 days ago • Promoted
    Design Engineer

    Design Engineer

    ArchKey Solutions LLC • Plymouth, MN, US
    Full-time
    This position is based in our Plymouth, MN office.ProKey Facilities delivers an innovative approach to all aspects of maintaining a facility – from problem solving to common sense solutions.Our tea...Show more
    Last updated: 30+ days ago
    Design Quality Engineer II (Maple Grove)

    Design Quality Engineer II (Maple Grove)

    JCW Group • Maple Grove, MN, US
    Part-time
    A leading global medical device company is seeking a Design Quality Engineer II to support sustaining systems engineering within a fast-growing cardiovascular division. This role will focus on ensur...Show more
    Last updated: 10 days ago • Promoted
    Design Assurance Engineer

    Design Assurance Engineer

    REQ Solutions • Osseo, MN, US
    Full-time
    Job Title : Design Assurance Engineer - Medical Device.Duration : 6+ Months (Possible extension).Location : Maple Grove, MN 55311. Develops, establishes and maintains quality engineering methodologies,...Show more
    Last updated: 1 day ago • Promoted
    Quality Engineer - Design Assurance (Minneapolis)

    Quality Engineer - Design Assurance (Minneapolis)

    JCW Group • Minneapolis, MN, US
    Part-time
    In this role, youll lead design assurance activities, support new product development, and ensure compliance with regulatory standards. Lead design assurance activities, including verification, vali...Show more
    Last updated: 10 days ago • Promoted
    Senior Design Assurance Engineer (Minneapolis)

    Senior Design Assurance Engineer (Minneapolis)

    JCW Group • Minneapolis, MN, US
    Part-time
    Senior Design Assurance Engineer.Youll lead design assurance activities, ensure compliance with regulatory standards, and collaborate with cross-functional teams to bring safe, high-quality product...Show more
    Last updated: 10 days ago • Promoted
    Mechanical Design Engineer

    Mechanical Design Engineer

    Applied Engineering • Burnsville, MN, US
    Full-time
    You will be part of a group of engineers dedicated to high quality work, value-add solutions, skill development, and career growth. Innovation, problem solving, integrity and collaboration are a few...Show more
    Last updated: 3 days ago • Promoted
    Design Quality Engineer II

    Design Quality Engineer II

    JCW Group • Maple Grove, MN, United States
    Full-time
    A leading global medical device company is seeking a Design Quality Engineer II to support sustaining systems engineering within a fast-growing cardiovascular division. This role will focus on ensur...Show more
    Last updated: 15 days ago • Promoted
    Design Engineer - Municipal

    Design Engineer - Municipal

    Bolton & Menk, Inc • Chaska, MN, US
    Full-time
    Bolton & Menk has an exciting opportunity for a Design Engineer, EIT, to join our Municipal team in our Chaska office.As a Top Workplace, this is a fantastic chance to work with a talented team...Show more
    Last updated: 30+ days ago • Promoted
    Design Quality Engineer III — Medical Device (Hybrid — Maple Grove, MN) Contract

    Design Quality Engineer III — Medical Device (Hybrid — Maple Grove, MN) Contract

    Pharmavise Corporation • Maple Grove, MN, us
    Full-time
    Quick Apply
    The Design Quality Engineer will support the application of design controls to projects focusing on design changes, material continuity, regulatory and standards compliance, corrective and preventi...Show more
    Last updated: 27 days ago