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Engineering Manager - Wheeling, United States - Michael Page
Description
Site Leadership Role|Established Contract Medical Device ManufacturerAbout Our Client
Our client is a global contract medical device manufacturer, with over 20 locations throughout North America.
They seek an experienced Engineering Manager, that will oversee their Sustaining Engineering Team and report to the Director of Operations.
Their customers include well known OEMs, such as Stryker, Medtronic and Smith & Nephew.This site is one of their largest in the Midwest, with over 200 employees and 3 buildings. The site is known for their culture, leadership team and stability.
This person will oversee a team of 9 full-time employees, including Engineers and Technicians and work cross-functionally with Production, Quality and Operations.
Job DescriptionLead and mentor a team of engineers and technicians responsible for sustaining engineering activities. Foster a culture of collaboration, innovation, and continuous improvement within the team.
Oversee all aspects of sustaining engineering projects, including planning, execution, and monitoring. Prioritize projects based on strategic objectives, customer needs, and regulatory requirements
Drive continuous improvement initiatives to enhance the performance, reliability, and manufacturability of existing medical devices. Work closely with cross-functional teams, including R&D, Quality, and Operations, to implement design changes effectively.
Identify opportunities for cost reduction through value engineering, process optimization, and supplier management. Develop and implement strategies to achieve cost reduction targets without compromising product quality or regulatory compliance.
Collaborate with the Quality team to ensure compliance with regulatory standards and industry best practices. Lead investigations into product quality issues, implement corrective and preventive actions, and drive root cause analysis efforts.
Maintain a thorough understanding of regulatory requirements applicable to medical devices. Ensure that all sustaining engineering activities comply with FDA regulations, ISO standards, and other relevant regulatory frameworks.
Partner with cross-functional teams, including Sales, Marketing, and Customer Support, to address customer feedback, support product launches, and drive customer satisfaction.
Ensure accurate and timely documentation of all sustaining engineering activities, including design changes, test protocols, and validation reports. Provide regular progress updates and reports to senior management.
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law.
The Successful Applicant
Bachelor's degree in Engineering or related field; advanced degree preferred.
10+ years of Manufacturing experience, with 5+ years in Engineering leadership roles
Medical device manufacturing experience is preferred
Proven track record of successfully managing engineering teams and delivering results in a fast-paced, regulated environment
In-depth knowledge of medical device regulations, including FDA QSR, ISO 13485, and MDD/MDR
Strong understanding of design control processes, risk management principles, and quality systems
Excellent communication, interpersonal, and leadership skills
Demonstrated ability to drive cross-functional collaboration and influence stakeholders at all levels of the organization
What's on Offer
Competitive base salary between $130,000-$150,000, depending on experience and skills
Bonus opportunity up to 15%, based on site performance, team and individual metrics
Estimated total package circa $175,000
17 Days of Paid Vacation + 10 holidays
401(k) with 3% company match
Comprehensive Medical, Dental and Vision Insurance Options - Employees are eligible on first day of employement
Medical/Prescription Drug Coverage - 3 Blue Cross Options (2 PPOs, 1 HDHP)
Health Savings Account and Flexible Spending Accounts
Dental Coverage - 2 Met Life Options
Life and AD&D Coverage
Short-term disability coverage
Tuition Reimbursement
Contact:
Alec Genter
Quote job ref:
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