Biomedical Engineering Director jobs in Racine, WI

About the Company: Family owned since 1908 Merz Aesthetics is the world’s largest dedicated medical aesthetics business. Choose Merz Aesthetics because it is unique - unique in our relationships with customers, in our products and in the way we treat each other.

The Associate Director/Director, Engineering is responsible to direct, coordinate, and provide technical expertise in all design changes, design transfers, design for manufacturability, and support quality on install base related activity. This role directs all engineering staff for Merz energy-based product portfolio with heavy interface with Merz R&D.

Key Responsibilities:

• Design Transfer- Direct employees in the design transfer and implementation of new development projects into manufacturing within design control requirements.
• Quality Support- Direct employees in the technical support of Manufacturing, Quality, and R&D to resolve product and/or safety issues.
• Manufacturing Support- Direct employees in creating strategy and authoring test plans and protocols for the validation and qualification of manufacturing processes and test methods.
• Technical Oversight- Support the development of product changes to further enhance device performance or operations.
• Compliance- Generate effective test reports while maintaining accurate records and documentation throughout the development and manufacturing process in order to comply with company and government standards and regulations. Represent the company in audits as required.
• Budget- Generate and maintain departmental budgets and oversee purchases, including capital projects and contracts, within specified approval limits. 
• Employee development- Manage and develop engineering staff in support of Merz North America business.

Education:

• BS Biomedical Engineering, Engineering, or Life Science Field. Required 
• MS/PhD in Business, Management, Engineering, or Life Science Field. Preferred

Experience:

Associate Director:

• Min. of 8 years engineering or similar experience in medical device, pharmaceutical or regulated industry. Required
• Min. of 3-5 years of experience in people management. Required

Director:

• Minimum of 10-12 years engineering or similar experience in medical device, pharmaceutical or regulated industry. Required 
• Min. of 5 years of experience in people management. Required 
• Minimum of 15 years engineering or similar experience in medical device or pharmaceutical industry, including employee management. Required 

Knowledge, skills, and abilities:

• Familiar with ISO 13485 / FDA QSR / GMP / Other medical industry regulations. Required 
• Knowledge of medical devices and associated materials and processes. Preferred
• Advanced skills in Microsoft Excel, PowerPoint and Word and comfort with large variety of online meeting tools and AV equipment. Preferred
• Knowledge of GMP requirements as relating to medical device development and manufacturing. Preferred
• Ability to communicate effectively with different stakeholders (internally and externally) in written form, orally and interpersonally. Required
• Experience with regulated audits. Preferred
• Strong technical and problem-solving skills. Preferred 
• Excellent time management skills, structured way of working and thinking. Preferred 
• Demonstrated history of teamwork and cross-functional collaboration. Preferred 

Benefits:

• Comprehensive Medical, Dental, and Vision plans.
• 20 days of Paid Time Off.
• 15 paid holidays.
• Paid Sick Leave.
• Paid Parental Leave.
• 401(k).
• Employee bonuses.
• And more!

Your benefits and PTO start the date you're hired with no waiting period!
Come join a company that is committed to being a trusted partner focused on our customers while not forgetting about our employees!