Product Engineering Manager

3 weeks ago


Schaumburg, Illinois, United States Sunstar Americas, Inc. Full time

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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