Manager, Engineering

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

Job summary

Integer Holdings Corporation seeks an experienced leader in Quality and Regulatory to drive product ramps and cost-reduction initiatives. You will guide QA/Regulatory alignment, supervise validations (IQ/OQ/PQ/PPQ), and apply Lean/Six Sigma to reduce waste and cycle times across manufacturing and business processes.

Ideal candidates have a BS in Engineering/Technical field, 10+ years in industry (5+ in medical devices), and a Six Sigma Black Belt.

Qualifications

• BS in Engineering/Technical field; advanced degree preferred.
• 10+ years experience; 5+ in medical device industry.
• Six Sigma Black Belt certification preferred; knowledge of ISO and regulatory standards.

Responsibilities

• Identify, track, resolve, and communicate major product ramps and cost reductions.
• Lead development and implementation of Quality and Regulatory requirements.
• Plan and ensure resources for IQ, OQ, PQ, PPQ validations.
• Promote Lean manufacturing to improve cycle times and reduce waste.
• Lead cross-functional projects with finance, HR, operations, quality and sales.
• Mentor junior staff and lead DMAIC project teams.

Skills

Leadership

Lean manufacturing

Six Sigma

Project management

Data analysis

Education

Bachelor's degree in Engineering/Technical field

Master's 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.CustomerWe focus on our customers’ successInnovationWe create better solutionsCollaborationWe create success togetherInclusionWe always interact with others respectfullyCandorWe are open and honest with one anotherIntegrityWe do the right things and do things rightAccountabilities & 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 facilityLeads the development and implementation of Quality and Regulatory requirements including Integer policies, procedures, and appropriate regulatory requirementsPlans, Develops, and ensures resources are adequate to execute Process and Test Method Validations (IQ, OQ, PQ, PPQ) in accordance with Integer procedures and guidelinesCommunicates 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 interactionsPrepares 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 processesPlans, 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 opportunitiesDemonstrates 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 resultsLeads staff performance management activities to improve capabilities and skills using regular objective setting and review process, performance appraisals and coaching of individual development plansDemonstrates technical ability through the application of engineering skills, approaches and knowledgePerforms other duties as required.Salary: 130,350-191,000Education & Experience:Minimum Education: Bachelor of Science in Engineering/Technical field, advance degree Master or PhD preferredMinimum 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.