Engineer, Project

Sunstar Americas, Inc. is a global leader in the oral care industry and the manufacturer and distributor of GUM oral care products and solutions. 

We serve dental professionals and consumers in 80 countries worldwide and are driven by a mission: to enhance the health and well-being of people everywhere through high-quality, innovative oral care products and solutions.

The Project Engineer is a key member of cross-functional teams responsible for design and development of strategic new product initiatives, product improvements, line extensions, and maintenance of existing products.    The Project Engineer coordinates with other functions and engineering staff to complete projects through a Stage-Gate development process while assuring compliance with relevant regulations required for the specific product classification.  The Product Engineer also provides expertise for product risk assessment and risk management activities and may act as study director for design verification including protocol design, testing, and reporting.  Responsible for material selection, analyzing test results, and recommending appropriate design changes.

In this position you will use your experience to:

• Design, develop, validate, and launch new medical devices, packaging, and labeling while complying with design control requirements as defined by FDA, ISO, and other global regulatory bodies.
• Support development, testing, and maintenance of packaging for chemical products of various classifications including drugs and devices.
• Help define, execute, and report on Engineering tasks related development projects. 
• Lead design efforts for product and packaging. Evaluate, select, and collaborate with suppliers of finished goods, components, and services, including direct interface with suppliers of numerous packaging materials, contract manufacturers, and design agencies. 
• Complete and release product specifications through the Engineering Change Notice process.
• Provide regular project status updates to Senior Management.
• Travel to suppliers globally to oversee project and production start-ups. 
• Act as study director for product and package verification testing including protocol design, analysis of test data, and authoring of final reports.
• Utilize CAD and other software programs to create timely, complete, and accurate specifications. 
• Maintain knowledge of industry technologies by planning and attending supplier presentations, plant visits, seminars, etc.
• Actively assist in process improvement activities providing input into related SOPs.
• Assist the Creative Services and Marketing departments by providing specification inputs for the development graphic designs applied to products, packaging, and literature.
• Advise the Marketing and Creative Services departments on technical and operational cost impact issues. 
• Interface with the cost accounting and purchasing departments to estimate costs for new and revised products throughout the design process. 

The ideal candidate will possess:

• Bachelor’s Degree in a related Engineering discipline (Mechanical, Manufacturing, Packaging, or equivalent)
• 5-7 years of experience in product design and development (medical device and/or drug/pharma experience preferred)
• Experienced with applicable device and drug product regulations (FDA, ISO, MDR, etc.)
• Experienced with development of new products and packaging (Knowledge of medical device design controls and Stage-Gate development preferred)
• Protocol development/study design
• Risk management activities (risk management plans, hazard analysis, risk assessment, DFMEA, risk mitigation, etc.)
• MS Project or equivalent 
• Experience with design for manufacturing including part design, assembly, automation, packaging and labeling processes 
• Knowledge of basic principles of injection molding and applicable material selection for specific applications

Benefits:

• Comprehensive insurance coverage that includes Medical, Vision, Life and disability insurance plans along with enhanced Dental benefits. 
• Company Paid Life & AD&D and Optional Life Insurance
• Flexible Spending and Health Savings Accounts
• Pet, Legal and Identity Theft Insurance Plans
• Employee Assistance Program
• Wellness program including an onsite fitness center. 
• 401K retirement plan with 5% employer match (Pretax and Roth options)
• 401k profit sharing contribution based on company performance 
• Paid holidays and generous paid time off. 
• Competitive annual bonus and sales incentive programs

Employee Perks:

• On-site café featuring daily specials with dinner-to-go options.
• Miles of beautifully maintained walking trails.
• Numerous employee appreciation events throughout the year. 
• Professional development and training classes 
• Flexible schedule including work from home options
• Employee discounts on oral care products