Manager, Engineering

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

Job summary

Integer Holdings Corporation is seeking an experienced engineering leader to drive quality, regulatory compliance, and cost-reduction initiatives across manufacturing and new product ramps. The role emphasizes Lean and Six Sigma leadership, cross-functional collaboration, and rigorous validation planning.

Ideal candidates will have 10+ years in manufacturing or medical devices, with a BS in engineering and advanced certifications preferred.

Qualifications

• Bachelor of Science in Engineering/Technical field required.
• Master's or PhD preferred for advanced roles.
• Strong leadership and ability to multi-task across programs.

Responsibilities

• Adheres to Integer’s Values and all safety, environmental, security and quality requirements including QMS, FDA regulations and company policies.
• Leads development and implementation of Quality and Regulatory requirements.
• Plans and ensures resources for IQ, OQ, PQ, PPQ validations.
• Communicates procedures and technical information clearly within Integer and with suppliers/customers.
• Drives Lean manufacturing techniques to reduce waste and improve cycle times.

Skills

Leadership

Multi-tasking

Prioritization

Education

BS in Engineering/Technical field

MS 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.

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

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.