Senior Design Assurance Engineer

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

The primary purpose of this job is to support new product development to ensure that the desired design

performance is achieved meeting the applicable medical device FDA/European regulatory requirements

and companies Policies & Procedures. The Design Assurance Engineer will ensure a successful transfer

of newly developed product to production, while supporting design phases concept through launch.

Key Accountabilities and Responsibilities

1. Adheres to GB 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.

2. 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.

3. 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.

4. 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.

5. Leads and provides guidance with Product Development Manufacturing Engineering in development of test,

develop production acceptance criteria, test methods, and process validation protocols.

6. 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.

7. Leads and provide guidance for root cause analyses investigations, preparation of CAPA and Distributed

Product Risk Assessment. Draft and update SOPs as required.

8. Performs other functions as required

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

Salary Range: $120,450 - $176,660

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.