Project Manager

Job Description This Project Manager role leads complex project initiatives within the medical device sector, with a primary focus on new product development from concept through commercialization. You will coordinate cross-functional teams, manage full product lifecycles, and ensure that project timelines, budgets, and resources align with customer requirements and regulatory standards. The position requires a strategic, hands-on leader who can drive project execution, maintain strong quality and compliance practices, and support business growth in a dynamic, highly regulated environment. Responsibilities * Lead and coordinate cross-functional teams to drive medical device product development projects from early concept through commercialization. * Develop comprehensive project plans that include detailed timelines, budgets, resource allocation, and risk management strategies. * Oversee and manage the entire product lifecycle, ensuring smooth transitions between development phases and alignment with business objectives. * Act as the primary point of contact for internal and external stakeholders, providing clear and regular project updates while managing expectations. * Ensure all projects comply with applicable regulatory requirements and internal quality system processes. * Facilitate effective communication and collaboration among engineering, quality, regulatory, and other functional teams to enhance project performance. * Identify, assess, and mitigate project risks to minimize impacts on timelines, budgets, and deliverables. * Conduct formal project reviews, capture lessons learned, and implement improvements to drive continuous enhancement of project management practices. * Support business development efforts by assessing project feasibility and evaluating potential impacts on timelines, profitability, and resource needs. * Collaborate with product development engineering teams, including catheter and other device-focused projects, to ensure technical requirements and customer specifications are met. * Develop and maintain risk management plans and project documentation in alignment with quality and regulatory expectations. * Cultivate strong customer relationships by understanding their needs, providing transparent updates, and ensuring delivery of high-quality products. * Mentor and guide junior project managers in project management best practices, tools, and processes. * Contribute to sustainable design initiatives and engineering management activities to support long-term product and portfolio success. * Support and help drive 510(k) projects by organizing remaining work, resolving issues, and ensuring successful completion and submission. Essential Skills * Bachelor's degree in Engineering, Business Administration, or a related field. * A minimum of 7 years of experience in project management, particularly within the medical device or highly regulated environment. * Demonstrated experience leading and managing the entire product lifecycle from concept through commercialization. * Proven track record managing complex projects with successful outcomes in terms of scope, schedule, cost, and quality. * Strong work history in product development processes, including engineering and new product development in medical devices, such as catheter-related projects. * Experience developing and executing detailed project plans, including timelines, budgets, and resource allocation. * Proficiency in risk management planning, including identification, assessment, and mitigation of project risks. * Experience working within and supporting robust quality systems management in a regulated industry. * Strong leadership skills with the ability to influence and coordinate cross-functional teams without direct authority. * Exceptional communication and interpersonal skills, with the ability to engage stakeholders at all levels. * Ability to manage multiple projects simultaneously while maintaining high attention to detail and organization. * Familiarity with FDA regulations and exposure to the 510(k) process. * Strong analytical and problem-solving skills with a results-oriented mindset. * PMP certification or equivalent project management credential (highly preferred). Additional Skills & Qualifications * Master's degree in Engineering, Business Administration, or a related field is preferred. * Experience in sustainable design and engineering management within a medical device or similarly regulated environment. * Work history in customer relations, including managing expectations and maintaining long-term partnerships. * Experience supporting or leading 510(k) submissions or similar regulatory pathways is a plus. * Demonstrated ability to mentor and coach junior project managers and team members. * Comfort working in a contract development and manufacturing environment with multiple concurrent projects. * PMP certification is highly preferred and will be considered a strong differentiator. Job Type & Location This is a Permanent position based out of Maple Grove, MN. Pay and Benefits The pay range for this position is $140000.00 - $160000.00/yr. * Employer subsidized health insurance for employees - Employer paid dental insurance - Employer HSA contribution - 401k plan with a company match - 9 paid holidays (including your birthday!) + PTO and Personal days - Gym membership subsidy - Employee Short Term Disability, Long Term Disability, and AD&D Life Insurance Workplace Type This is a fully onsite position in Maple Grove,MN. Application Deadline This position is anticipated to close on Jul 15, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email View email address on click.appcast.io for other accommodation options. San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records. Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.