- Lead 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.
- 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
- 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
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Manufacturing Engineering Manager - Buffalo Grove, United States - Michael Page
Description
Our client is a global contract medical device manufacturer, with over 20 locations and 5,000 employees throughout North America They seek an experienced Engineering Manager, that will oversee their Sustaining Engineering Team and report to the Director of Operations.
Client Details
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.
Description
This role will be responsible for managing a team of engineers and technicians focused on sustaining engineering activities, including product improvements, cost reduction initiatives, quality enhancements, and regulatory compliance.
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