Manager, Engineering

Integer Holdings; Brooklyn Park (MN); On-site; USD 100,000 - 130,000; Full time

Benefits offered by this job

Comprehensive benefits package

401(k) plan with matching contributions

Parental leave after one year

Job summary

A leading medical device company seeks an experienced engineering leader to oversee regulatory compliance, lead projects, and mentor junior staff. The ideal candidate will have over 10 years of relevant experience, with at least 5 years in the medical device industry. Strong leadership, Six Sigma certification, and a Bachelor's degree in Engineering are required. This position offers competitive compensation and a comprehensive benefits package, including medical and a 401(k) plan with matching contributions.

Qualifications

• Minimum of 10+ years of experience, 5+ in medical device industry.
• Strong leadership and multi-tasking skills are essential.
• Six Sigma Black Belt certification preferred; knowledge of ISO required.

Responsibilities

• Lead development and implementation of Quality and Regulatory requirements.
• Use Lean and Six Sigma methods to improve process flows.
• Manage project activities with cross-functional teams.

Skills

Leadership skills

Project management

Multi-tasking

Lean manufacturing techniques

Statistical analysis

Education

Bachelor of Science in Engineering/Technical field

Master or PhD (preferred)

Tools

Lean Leadership methods

DMAIC - Six Sigma

Job description

Overview

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.

Values

• 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 where 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.

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.

Total Rewards

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.