Testing Engineer II- Chaska

Integer Holdings Corporation; Chaska (MN); On-site; USD 79,000 - 116,000; Full time

Benefits offered by this job

Medical insurance

401(k) with company match

Paid time off

Job summary

Integer Holdings Corporation is seeking a quality-focused engineer to join our team in Minnesota. You will participate in development projects, execute validation and test methods, and collaborate across DA, R&D, and NPI teams to ensure robust design verification and validation processes.

The role requires a bachelor’s degree in engineering with several years of related experience, strong problem-solving skills, and familiarity with QMS and regulatory standards.

Qualifications

• Bachelor's degree in engineering or related field and 3+ years of relevant experience; 7+ years may substitute education.
• Experience with quality systems and design controls.
• Ability to interpret design schematics and drawings.
• Strong written and oral communication, technical writing.

Responsibilities

• Adhere to ISO/FDA quality and safety requirements and company procedures.
• Participate in development project teams; perform quality/reliability activities.
• Generate and execute validation protocols and reports (IEQ, PQ, TMV, SWIQ).
• Support test protocols execution and DA lab activities.
• Collaborate with R&D and NPI teams to develop test methods and documentation.
• Lead improvements for legacy test methods.
• Assist with CAPA and risk assessment; update SOPs as needed.
• Review and approve engineering change requests.

Skills

Minitab

Problem solving

FDA/ISO knowledge

Schematics interpretation

ANOVA/DOE/SPC

Lean sigma tools

Lab equipment

Mechanical testing

Education

Bachelor's degree in engineering

Tools

SolidWorks

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.

Key Accountabilities and Responsibilities

1. 1. 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.
2. 2. 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.
3. 3.Responsible to generate and execute validation protocols and reports (IEQ,PQ, TMV, SWIQ) for design verification test methods.
4. 4.Support DA lab staff during design verification and design validation protocols execution (test).
5. 5.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.
6. 6.Drive and support continuous improvement initiatives for legacy test methods.
7. 7. Provides support for root cause analyses, CAPA and Distributed Product Risk Assessment and updates SOPs as required.
8. 8.Initiates, reviews, and approves engineering change requests and documentation.
9. 9. Performs other functions as required.

Specialized Knowledge

1. 1. Experience with statistical software packages such as Minitab.
2. 2. Demonstrated problem solving skills.
3. 3. Knowledge of ISO and FDA quality, process validation and system requirements.
4. 4. Experience in interpreting design schematics and drawings.
5. 5. Skilled in statistical methods e.g. ANOVA, SPC, sample size determination, Gauge R&R and DOE.
6. 6. Knowledge of quality lean sigma tools (e.g. Root Cause Analysis, QFD, Ishikawa, Kepner-Tregoe.)
7. 7. Experience with Lab Measurement equipment (Microscope, Caliper, Multimeter, Tensile tester, Vision Systems, etc).
8. 8. Knowledge of mechanical and electrical test methods (Tensile, 3-point bend, coating performance, torqueability, trackability, fatigue tip stiffness, leak test, continuity, resistance, particulate. Etc).
9. 9. Solid works experience.

Job Requirements

Minimum Education: 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. While you will have occasional support and guidance from more experienced engineers, supervisors or managers, you will demonstrate the ability to work independently as well as collaboratively with other associates and cross functional teams.

Special Skills

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.

Salary Range

Salary Range: $79,200-$116,160

Benefits

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.

Equal Opportunity & Diversity

U.S. Applicants: Equal Opportunity Employer.

In addition, veterans and individuals with disabilities are encouraged to apply.

Integer 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.

Accommodation Contact

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 [phone] or via [e-mail] 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 https://integer.wd1.myworkdayjobs.com/en-US/External/login

Remote Eligibility

For remote eligible job postings, all work should be performed entirely outside of Alaska, California, Hawaii, Maine, Montana, and Washington.

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Closing

Thanks for your interest in working on our team!!