Manager, Engineering

Integer Holdings Corporation; Brooklyn Park (MN); On-site; USD 130,000 - 191,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

Life insurance

Adoption benefits

401(k) with company match

Paid time off

Job summary

Integer Holdings Corporation is seeking a senior engineering leader to drive Quality and Regulatory initiatives across facilities. You will champion Lean and Six Sigma approaches, lead major product ramps, and coordinate cross-functional teams including finance, HR, operations and sales.

The role emphasizes mentoring, process optimization, and adherence to FDA and ISO standards. A BS in engineering with 10+ years of experience (5+ in medical devices) is required.

Qualifications

• BS in Engineering/Technical field required; 10+ years total experience (5+ in medical devices).
• Six Sigma Black Belt and ISO regulatory knowledge preferred.
• Strong leadership and cross-functional collaboration skills.

Responsibilities

• Adheres to Integer's safety, environmental, quality and regulatory requirements.
• Identify, track, resolve and communicate major new product ramps and cost initiatives.
• Lead development and implementation of Quality, Regulatory policies and procedures.
• Plan resources to execute IQ/OQ/PQ/PPQ per procedures and guidelines.
• Communicate procedures, improvements and technical info clearly inside and outside the company.
• Prepare or review documentation (specs, procedures, ECOs, reports) with accuracy.
• Apply Lean leadership to improve cycle times and reduce waste in processes.
• Lead DMAIC projects to reduce variation across processes.
• Plan, execute and manage cross-functional projects (new products, transfers, continuous improvement).
• Mentor staff, drive accountability, and develop team capabilities.
• Demonstrate engineering knowledge through practical application.
• Perform other duties as required.

Skills

Leadership

Multi-tasking

Lean manufacturing

Six Sigma Black Belt

Regulatory knowledge (ISO)

Education

Bachelor of Science in Engineering/Technical field

Master or PhD preferred

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.

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

Accountabilities & Responsibilities

• Adheres 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.
• Responsible for identifying, tracking, resolving, and communicating major new product ramps and cost reduction initiatives at a facility
• Leads the development and implementation of Quality and Regulatory requirements including Integer policies, procedures, and appropriate regulatory requirements
• Plans, Develops, and ensures resources are adequate to execute Process and Test Method Validations (IQ, OQ, PQ, PPQ) in accordance with Integer procedures and guidelines
• Communicates procedures, policies, improvement ideas, technical information, and recommendations clearly, effectively and frequently (oral and written) within Integer, with outside suppliers or partners and with Integer customers during formal and informal interactions
• Prepares or reviews documentation with a high degree of accuracy, completeness, and effectiveness using common Integer engineering tools & templates were available. (Examples include specifications, manufacturing procedures, ECOs, and technical reports or analysis)
• Using Lean Leadership experience, applies and Promotes Lean manufacturing techniques to continuously improve cycle times and process flows. Identifies and directs the execution of improvement efforts to reduce waste in all manufacturing and business processes Uses structured problem solving techniques and statistical methods for data driven analysis and decisions.
• Using Black Belt experiences, leads DMAIC – Six Sigma approaches to solve issues and reduce variation in all manufacturing and business processes
• Plans, executes and manages project activities with cross functional teams including finance, human resources, operations, quality and sales. Project types can include new product development and introduction, manufacturing transfers, continuous improvement and cost reduction initiatives, quality improvements and sales opportunities
• Demonstrates leadership through mentoring of junior staff, responsiveness to business needs and motivation of diverse, cross functional teams including influencing both internal and external members to achieve positive business results
• Leads staff performance management activities to improve capabilities and skills using regular objective setting and review process, performance appraisals and coaching of individual development plans
• Demonstrates technical ability through the application of engineering skills, approaches and knowledge
• Performs other duties as required.
• Salary: 130,350-191,000

Education & Experience

Minimum Education: Bachelor of Science in Engineering/Technical field, advance degree Master or PhD preferred

Minimum Experience: 10+ years of experience (5+ in medical device industry)

Knowledge & Skills

Special Skills: Strong leadership skills. Ability to multi-task and prioritize projects.

Specialized Knowledge: Six Sigma Black Belt certification preferred. Knowledge of ISO and regulatory standards is a must.

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.