Position Summary

The Project Manager will lead and drive New Product Development projects from cross-functional team inception to Full Market Release as well as manufacturing-related projects focused on continuous improvement and general sustaining activities. The programs and projects managed by the Project Manager represent critical strategic imperatives and are global in both scale and scope and have direct visibility to Senior Management. This position is expected to be strategic and forward thinking, expected to learn and implement new processes and ideas, and consistently find ways to better our processes, improve timeline opportunities, and not be satisfied with the status quo. The recommendations from the Project Manager and cross-functional teams have impact on the division affecting the financial, employee and customer view of the company.

Duties

• Directs all phases of medical/dental device program and project development from cross-functional team inception, completion of a commercialized product, launch, post-market surveillance and change control.
• Organizes and leads cross-functional teams on multiple life science/medical/dental device new product development and change control projects that may include, at varying complexity, the following:  major new products; major and small line extensions; major redesigns; sourcing projects; inter-divisional projects; manufacturing projects; laboratory projects; continuous improvement projects; and value improvement and business continuity projects.
• Serves as a proactive interface between Scientific, Engineering, Marketing, Clinical, Manufacturing, Regulatory and Quality to ensure effective progression and delivery of projects. Develops and drives the cross-functional plan/strategy as well as execution of new products and change control projects directed by the Value Stream.
• Provides leadership, mentoring, scientific and technical expertise to ensure high quality products for the marketplace are delivered right the first time. Has a ‘can-do’ attitude and strong customer service approach to internal customers in order to bring team together and get work completed.
• Ensures the New Product Development and Change Control Project process is followed.  Owns the overall program and project management of the product development to ensure targets are met for performance, features, quality, costs, reliability, manufacturability, etc.
• Creates, monitors and updates project plans. Defends due dates when obstacles arise by helping the team come up with alternative solutions and plans to achieve the end goal.
• Acts as the primary leader for assigned program and project activities, leading review sessions to discuss project status, critical paths, risks, and milestones. Has core knowledge of other job functions to help complete critical path items. 
• Enables team to create a basic timeline together and establishes milestones and monitors adherence to master plans and schedules.  Identifies program or project problems and obtains solutions such as allocation of resources or changing specifications.
• Facilitates and follows-up with the assigned cross–functional team members involved in product definition, design, development, production, scientific, regulatory, quality, marketing, and clinical applications.
• Facilitates communication and interaction among functional business heads to ensure transparency of critical deliverables and milestones in the New Product Development and Change Control Project process

• Delivers critical, timely communications to the Senior Leadership Group on product development and delivery.
• Ensures smooth transition across the organization for initial concept through product development, manufacturing, design limited market release, product launch and change control. Uses Visual Management, meeting agendas, meeting minutes and other tools to communicate progress and roadblocks to all levels of the organization.
• Identifies critical dependences, risks, and contingency plans.  Proactively monitors progress, anticipating the effect of dependencies on schedule, cost, etc.
• Participates in identifying and implementing improvements and updates to the New Product Development Project and Change Control Project process, including adding deliverables, tools and/or processes to address functional and product requirements.
• Provides performance feedback regarding cross-functional team members to appropriate Functional Managers.
• Leads Voice of Customer initiatives and works closely with Product Management to define customer/market requirements for new products development.
• Identifies problems and is responsible for determining solution to changes in program or project requirements, resource allocation issues, changes in project scope, etc. while fully understanding the trade-offs being made that impact the overall New Product Development and Change Control Project process and financials for the business. Decisions may have potential impact in all internal functions involved in producing a commercialized product.
• Responsible for the outcomes of the cross-functional team and its impact to the overall product development.  Must create the vision and set direction for the core team, keep all members engaged through the process, recognize and reward team members as appropriate and provide coaching and performance feedback for each member.

Education Degree

Required Experience

• Bachelor’s degree, Technical degree in the sciences or engineering fields highly beneficial; Master’s degree is a plus
• Minimum 5 years’ experience; minimum 3 years in program, project or portfolio management associated with product development and change control in a medical/dental device, pharmaceutical or a regulated industry
• Experience in more than one of the following disciplines a plus: Scientific, Design and/or Development Engineering, Product Marketing, Finance, Manufacturing, Regulatory, Quality
• Strong project management skills required; PMP certification a plus

Skills

• Experience leading projects from initial concept, through development, 510(k) submission and verification/validation testing, and into Manufacturing or testing services through product/process launch.  Ability to balance Customer needs; manufacturing, laboratory, business, and regulatory requirements to expedite launch of the right new product development products and change control projects to market.
• Experience successfully managing programs and projects through life science/medical/dental device, New Product Development, and Change Control Project process. Track record of managing projects to schedule and budget.
• Demonstrated proficiency in program and project management tools and procedures for setting and tracking performance, quality, time, and cost; strong planning and organization skills required.
• Requires knowledge of regulatory environment (Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and applicable Quality System Standards). 
• Ability to effectively handle conflict through proactive action, and direct and timely communication.
• Demonstrated leadership skills including conflict resolution, assertiveness and negotiation skills are required.  
• Ability to lead and collaborate within a team-based matrixed organization across all business functions, levels, and cultures.  Experience in successfully coordinating with functional departments (e.g., Scientific, Engineering, Legal, Regulatory, Operations, Materials & Logistics, Clinical Affairs, Marketing, Quality, etc.).
• Excellent interpersonal and influence management skills including evidence of managing multi-disciplinary teams.
• Demonstrated critical thinking - ability to make sound data driven business decisions; understand, track, drill down and question activities and issues in all functional areas.
• Strong attention to detail, follow-through skills and experience to check behind the scenes to ensure surprises are minimized.
• Excellent written, oral and presentation skills.
• Ability to quickly learn product discipline. 
• Sets the standard for timeliness, work ethic, and personal integrity.
• PC literate; Microsoft Project.

Equal Employment Opportunity & Accessibility Statement
HuFriedyGroup is an equal-opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We prohibit discrimination and harassment of any kind based on race, color, religion, age, gender, national origin, disability status, genetics, veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

If you require reasonable accommodations to apply for a position, participate in the recruitment process, or perform essential job functions, please contact us at 773-868-5534. We are committed to supporting you throughout your journey with HuFriedyGroup!