Product Engineering Manager
3 weeks ago
About the Role:
Sunstar Americas, Inc. is seeking a highly skilled Product Engineering Manager to lead our engineering team in developing and optimizing oral care medical devices and drug products. The ideal candidate will have a strong background in medical device engineering, exceptional leadership skills, and the ability to navigate both in-house and contract manufacturing environments.
Key Responsibilities:
- Team Leadership: Lead and mentor a team of product engineers, fostering a collaborative and innovative work environment. Provide guidance on technical challenges and career development.
- Product Development: Oversee the design, development, and qualification of Class 1 and 2 medical devices and OTC drug products, ensuring they meet quality standards and regulatory requirements.
- Cross-Functional Collaboration: Work closely with new product development, quality assurance, regulatory affairs, and marketing to align product strategies and timelines. Facilitate communication between internal teams and external partners.
- Project Management: Manage multiple engineering projects simultaneously, ensuring they are delivered on time and within budget. Develop project plans, track progress, and report on status to senior management.
- Manufacturing Oversight: Collaborate with contract manufacturers in China and other regions to ensure the successful production of devices. Evaluate supplier capabilities and performance, and lead efforts to optimize manufacturing processes.
- Regulatory Compliance: Ensure all products are designed and manufactured in compliance with FDA regulations and industry standards. Participate in design reviews and risk assessments.
- Continuous Improvement: Identify opportunities for process improvements in product development and manufacturing. Implement best practices to enhance efficiency, quality, and innovation.
Requirements:
- Bachelor's degree in Engineering (Mechanical, Biomedical, or related field); Master's degree preferred.
- Minimum of 7 years of experience in product engineering or development, preferably in the medical device or oral care industry.
- Proven experience managing engineering teams and leading the engineering aspects of product development projects.
- Strong understanding of FDA regulations and ISO standards related to medical devices.
About Sunstar Americas, Inc.:
- A business focused on health and wellness of people around the world
- High Quality Products
- Beautiful state-of-the-art facility
- Diversity and Inclusion
- Corporate Social Responsibility Program and partnership with charitable organization
- Strong value placed on company culture
- Excellent, comprehensive insurance coverage that includes Medical, Vision, and Dental benefits.
- Opportunities for career growth and advancement
- Employee discount on Sunstar products
- 401K retirement plan with 2.5% employer match (Pretax and Roth options)
- 401K profit sharing contribution based on company performance.
- Paid holidays and generous paid time off. Pet, Legal and Identity Theft Insurance Plans
- Competitive bonus
- On-site café
- On Site Fitness Center
- Corporate Perks Discount Program (Auto, Retail, Electronics, Entertainment, Computers, Personal Vacations, Cell Phones, Movie Tickets, Eating Out and Much More)
- Holiday Lunches
- Beautifully maintained walking trails
- Hybrid Schedule (certain departments)
- Numerous employee appreciation events throughout the year.
- Recognition and Rewards Programs
- Anniversary, Birthday and New Hire Announcements
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