Job Description
Description:
The Project Manager, Combination Products Development is accountable for leading the cross functional team (Engineering, Quality, Supply Chain, Marketing, Operations, Human Factors, and External Partners) in the execution of a portfolio of projects focused on the delivery system constituent parts of a combination product (Devices, Accessories, Instructions for Use, etc.).
The Project Manager ensures that the strategy and plans defined for assigned programs are aligned with the needs of the patient and customer and the business objectives of the CMC and Product Strategy teams.
In addition, product development timing and scope need to support plans for CMC gate reviews and each clinical phase.
The Project Manager will be accountable to the Program Manager Director for delivering on the strategy, plans and budget defined for the project portfolio.
Leadership of a portfolio of drug delivery system product development projects
Tactical and strategic management of external device partners including acting as a key interface, managing the project governance process and forward-looking evaluation of potential partners
Device financial management including budgeting, forecasting and long-range planning of delivery development expenses
Representing the R&D organization to cross functional leadership through effective and timely communication
Ensuring effective use of meetings by clearly defining objectives, agendas, inviting the team members specifically needed and publishing minutes and actions
Qualifications
Required: Bachelor's degree in engineering (mechanical or biomedical engineering).
Master's degree in engineering or management is preferred but not required.
Certification: Project Management Professional (PMP) Certification preferred, but not required
8+ years of experience in the combination product or medical device industry with proven experience in developing medical devices or combination products; broad experience in design controls, human factors studies, design verification/validation and usability studies.
Leadership: Ability to motivate teams, delegate tasks effectively, and drive project success.
Communication: Excellent written and verbal communication skills to manage stakeholders and team members.
Risk Management: Expertise in identifying, assessing, and mitigating project risks.
Scheduling & Organization: Proficiency in planning, prioritizing tasks, managing timelines, and using project management tools.
Problem-Solving/Process Improvement: Strong analytical skills to resolve issues and adapt to changing project requirements.
Requires an in-depth understanding of the pharmaceutical and device product development cycle.
Design history file, project management and product development experience is essential.
Benefits:
Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.
Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.
Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.
Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.
Synectics is an equal opportunity employer.