Mission

Manage new product projects (consisting of Class I and II medical devices, drugs, and cosmetics) from idea to commercialization by leading cross-functional development and implementation teams.

Key responsibilities

• Work with project sponsors to define project scope, budget, and financial justification models
• Draft agendas for and lead cross-functional team meetings focusing on defining and tracking key project milestones and deliverables
• Draft and maintain complete project timelines
• Ensure projects follow internal Stage-Gate process
• Provide project status updates to Senior Management on a regular basis
• Ensure products follow ISO and FDA regulations regarding design controls
• Document meeting summaries, key decisions, and action items
• Follow up regularly with team members for status updates
• Identify project issues and risks early and work with stakeholders on solutions to minimize impacts to schedule and budget.

What we’re looking for

• Bachelor’s degree required
• PMP certification preferred
• 7 or more years of experience leading projects within the medical device field
• Thorough knowledge of design control regulations for medical devices; specifically, ISO 13485 and FDA 21 CFR part 820
• Experience managing projects within a Stage-Gate development framework or similar
• Experience leading cross-functional teams focused on product development
• Experience using electronic project scheduling methods such as MS Project
• Experience writing and presenting detailed project reports to Executive Management
• Experience leading projects in a manufacturing environment
• Experience applying financial models for benefit of project analysis (such as NPV, IRR)
• Ability to recognize priorities and deliver results under time constraints
• Ability to lead and motivate team members while providing timely and accurate project communications to the organization
• Ability to deliver clear and professional presentations to Executive Management members
• Ability to handle multiple projects concurrently
• Ability to shift priorities when necessary to react to changing project requirements
• Ability to identify and solve problems as they arise

What Makes Sunstar Special is:

• 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 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

If you’d enjoy a career helping others attain overall health through oral health, consider joining the Sunstar Americas, Inc. team.

The employer is subject to certain governmental record keeping and reporting requirements for the administration of civil rights laws and regulations. To comply with these laws, the employer invites employees to voluntarily self-identify their gender, race or ethnicity. Completion of this data is voluntary and will not affect your opportunity for employment or terms or conditions of employment. Information collected will be used for EEO-1 reporting purposes only and will be kept separate from all other personnel records, only accessed by Authorized Users. Information collected will be kept confidential and will only be used in accordance with the provisions of applicable laws, including those that require the information to be summarized and reported to the federal government. When reported, data will not identify any specific individual.

The pay range for this position of Project Manager is $104,460- $156,690. However, base pay offered may vary depending on skills, experience, job-related knowledge and location. This position is also eligible for an annual bonus as part of total compensation.