Job Title: Engineering Project Manager
Mansfield, MA, US, 2048
We are searching for an experienced Engineering Project Manager who will assume leadership responsibility to plan, monitor and execute customer or internal projects. You will coordinate multiple functions within Paragon Medical Mansfield to ensure that contractual commitments are met while maximizing Customer satisfaction and Paragon Medical’s business benefits. Effective Project Management is a major factor in ensuring success for New Business. You will work in our Mansfield, MA location.
ESSENTIAL DUTIES AND KEY RESPONSIBILITIES:
You will be a leader of a product, process, or technology development for projects. This role works directly with clients to drive projects forward, mitigate risk, and steer decisions critical to project success. You will coordinate with other departments to fulfill the demands of each phase within each project.
- Initiate, plan, execute and complete the product development and new product introduction processes for disposable and reusable medical devices, instrumentation systems and/or capital equipment
- Establish effective, professional communications, confidence and trust with a variety of client stakeholder backgrounds and company sizes
- Identify and manage project scope by developing and implementing the project plan, building team ownership and commitment to proposal deliverables while ensuring alignment with stakeholder expectations.
- Ability to quickly grasp the client’s user requirements and help the team define product specifications
- Drive brainstorming activities, evaluate options and recommend alternatives
- Coordinate the design, procurement, and fabrication of products and process tooling and fixturing; providing guidance to technology implementation teams, driving progress and recommending appropriate revision
- Demonstrate effective risk management strategies providing critical information to clients enabling informed collaborative decisions on product direction
- Effectively lead cross-functional teams; provide input and direction on performance, confirm adherence to quality policies and standard operating procedures while overseeing the initial product testing as well as subsequent design verification and validation activities.
- Effectively lead cross-functional teams, managing assigned resources in coordinating process validation activities to include IQ/OQ/PQ.
- Interface with the customer, conduct project meetings and generate concise meeting minutes with clear action items
- Review client invoices and track project costs working to keep teams on task, on time, and on budget
- Creates cost estimates for change of scope documents
- Organize project documentation and generate and maintain the Design History File
- Plan, lead and document all formal Design and Phase review meetings
- Assist with or prepare and present proposals to customers for additional product and process development efforts
- Assist Quality function with client or Regulatory Agency audits relating to Design Controls
- Prepare and present regular project status reports to stakeholders, reporting on project health, timeline and budget management.
- Report project outcomes and/or risks to the appropriate management channels and escalate issues, as necessary, according to project work plan
EDUCATION and/or EXPERIENCE
Required:
- Bachelor’s in Mechanical Engineering or another Engineering or Technical field
- Minimum of seven (7) years of experience in product development of medical devices
- Three (3) years involving project management
Skills/Competencies:
- Broad experience with manufacturing methods for precision parts including machining, injection molding and extrusion (experience with plastic assembly and joining processes a plus).
- Thorough knowledge of Medical Device Quality systems to include ISO, GMP, and QSR standards.
- Highly complex technical problem solving and solid analytical skills.
- Computer proficiency to include Microsoft Office and SmartSheet.
- Demonstrated ability to lead people and get results through others.
- Excellent interpersonal, communication, and presentation skills
- Excellent professional written communication skills
- Excellent project and program management skills
Paragon Medical, a business of AMETEK, Inc, serves as a strategic partner in medical device manufacturing, offering an end-to-end supply chain solution from initial concept and product development, to verification and validation testing, to final production, assembly, and ongoing strategic demand planning.