Summary:

The New Product Introduction Project Manager is directly responsible for managing both new and existing projects under Product Development and Manufacturing Transfer processes while ensuring project schedules, project budgets, product cost, and product performance metrics achieve Client requirements.
 
The position reports directly to the Head of Product Development

Key Accountabilities:

Project Ownership/Management – 30%
Accountable to ensure that the assigned projects are initiated once proposal is signed, purchase order received, and project deposit is obtained. Management of project(s) will include ownership of project schedule, project budget, product performance, product cost, and acting client point of contact throughout the project’s lifecycle.
 
Lead, Manage, Develop, and Hold Accountable – 15%
Accountable to coach functional team members and less experienced functional group members pertaining to Project Management to grow their capability and ensure quality of project for the organization.
 
Product Development Management – 20%  
Accountable to manage to project closure or continuation of project to Manufacturing Transfer to ensure that Client product performance, product safety, product regulatory, and product quality requirements are achieved.
 
Manufacturing Transfer Management – 20%
Accountable to manage the project closure or project “transfer” to Production to ensure that Client product manufacturing process efficiency, process cost, and process quality requirements are achieved.

Business Development and Marketing Support – 5%  
Accountable to support business development and marketing activities through promotion of company reputation, company services, proposal development, marketing material development, and new client interactions to ensure a healthy project pipeline.
 
Continuous Improvement (Optimize and Innovate Culture) – 10%
Accountable to optimize and innovate through leadership influence, management methods and functional group processes.

Primary Responsibilities:

Project Ownership/Management – 30%

• Work directly with Quality Assurance Manager and Production Project Manager to ensure that all projects seamlessly transition through all functional groups while meeting delivery, budget, and quality specifications.
• Once assigned, the Project Manager is required to facilitate the Pre-Project internal review meeting with all affiliated functional team members, ensuring company practices are in alignment prior to moving into the product development and/or manufacturing transfer phase.
• Take ownership of coordinating processes for assigned projects concerning all resources, labor, materials, design details, schedule, and budget.
• Responsible to act as the ‘point of contact’ for the client once assigned project from Head of NPI, ensuring client engagement on a consistent basis and answering subsequent questions within reason.
• Responsible to partner with Operations and Quality functional group personnel to identify all long lead items to build an accurate timeline for delivery for the entire project.
• Assign approved and available functional team members and resources who will drive and support project phases.
• Input billable time on a daily/weekly basis for assigned projects to ensure Client budget is on track and billable time is recorded to prevent loss of revenue.
• Track billable time on a weekly basis for all resources on assigned projects to ensure Client budget is on track and billable time is recorded to prevent loss of revenue.
• Represent the project metrics and schedule in Client communication to drive precise schedule, budget, and metrics, ensuring all project phases meet Clients’ needs and expectations.
• Update Clients throughout projects in pre-determined check-ins (i.e. weekly check-in meetings and monthly progress reports) to manage feedback, potential schedule conflicts and/or unforeseen requests.
• Coordinate the response to all design and process Product Development change orders and ensure Quality Assurance Manager, and Production Project Manager are in alignment for change order procedure and solutions.
• Complete EOM / Inventory tracking for projects in early-stage production to facilitate client invoicing.

Lead, Manage, Develop, and Hold Accountable – 10%  

• Responsible to coach less experienced functional group team members pertaining to project management and new product introduction to develop the company’s capability.
• Peer review project team members plans/output to ultimately help improve their project plans, management of details and metrics. 
• Coach team members on working across the organization to drive collaboration towards a common goal so the company meets its commitments, schedules, and profitability goals by project.
• Develop Position Expectations and Performance Evaluations for assigned direct reports to identify self-development and skill training requirements to improve associate efficiency, communication, team player, and quality of work output.   

Product Development Management – 20%  

• Drive development or remediation of Client design history file (DHF) per scope of work listed in Client proposal to ensure regulatory compliance and Client design performance requirements are achieved.
• Track and report Client design performance, design safety, design regulatory, and design quality requirements to ensure budget and schedule are achieved.
• Drive the integration of project deliverables across all functional groups to enable the company to meet deliverables, schedule, and budgets to meet client requirements.
• Ensure design reviews are held with the assigned functional team members prior to releasing schedule to minimize confusion and scheduling issues.
• Drive the design change process to ensure that issues are identified, resolved, and implemented to minimize impact to the Product Development schedule.
• Select, approve, and partner with suppliers and third-party consultants to ensure delivery and product completion align with project timelines and expectations.
• Facilitate post-project retrospectives to understand the project successes measured against original client requirements.

Manufacturing Transfer Management – 20%

• Drive development or remediation of Client device master record (DMR) per scope of work listed in Client proposal to ensure regulatory compliance and Client product performance requirements are achieved.
• Track and report weekly Client process efficiency, process cost, and process quality requirements to ensure budget and schedule are achieved.
• Drive the integration of project deliverables across all functional groups to enable the company to meet deliverables, schedule, and budgets to meet client requirements. 
• Ensure process reviews are held with the assigned functional team members prior to releasing schedule to minimize confusion and scheduling issues.
• Support the dispositioning of non-conformities to ensure that they are corrected and the impact to the Product Development schedule is minimized.
• Select, approve, and partner with suppliers and third-party consultants to ensure delivery and product completion align with project timelines and expectations.
• Facilitate post-project retrospectives to understand the project successes measured against original client requirements.

Business Development and Marketing Support – 5%

• Support business development activities such as trade shows and industry events through research, setting up logistics, attending, and pitching business model to potential Clients   to ensure a steady Client lead pipeline.
• Lead new Client proposal development through obtaining project details, drafting proposal, creating budget, Q&A with Client, and reviewing proposal prior to submission to Client.

Continuous Improvement Culture – 10%

• Maintain effective communication through project management consistently to surface systemic improvements.
• Maintain and improve the project management process to improve schedule and profit.
• Communicate through Operations meetings to provide real time key metric performances and feedback to drive improvements in cost and quality issues for the organization.
• Drive a ‘best practice’ and continually improving culture throughout the organization. 
• Acknowledge and reward team members for contributions on a regular basis when role model behaviors are exhibited.
• Maintenance and improvement of ERP system practices and functionality and support training and resolution to issues.

Education / Experience Requirements:

• Minimum Requirements: BSEE, BSME or related degree
• Minimum of three (3) to four (4) years medical device product development and/or medical manufacturing environment experience.

Company Values:

Grit & Wit
We bring our full selves to work—humor, honesty, and humanity included. We respect different perspectives, don’t take ourselves too seriously, and know that real connection strengthens the determination and teamwork it takes to reach ambitious goals.
 
Solve Forward
We stay clear on what matters most, adapt with intention, and move fast toward solutions. With resilience, creativity, and focus, we turn challenges into progress—navigating complexity with clarity, calm, and purpose to drive real results.
 
Transparency & Trust
Building strong, transparent relationships with our clients is at the core of our work. We believe in being upfront, honest, and open, ensuring that our clients always have the full picture and trust us as true partners.
 
Maximizing Client Value
We challenge our assumptions, stay disciplined in execution, and approach every challenge with a positive, forward-thinking mindset. By continuously striving for better—smarter solutions, sharper focus, and stronger relationships—we maximize value for our clients and our company.