Nextern is seeking a Sr. Project Manager to lead and manage complex project initiatives in the medical device sector. This role requires a strategic thinker who can coordinate new product development while ensuring alignment across multiple departments and stakeholders. You will be responsible for overseeing project timelines, budgets, and resources to deliver high-quality products that meet customer specifications and regulatory standards.
DUTIES AND RESPONSIBILITIES:
- Lead and coordinate cross-functional teams to drive product development projects from concept through commercialization.
- Develop comprehensive project plans, including timelines, budgets, resource allocation, and risk management strategies.
- Act as the primary point of contact for internal and external stakeholders, providing regular project updates and managing expectations.
- Ensure compliance with regulatory requirements and Nextern’s quality system processes.
- Facilitate effective communication and collaboration among team members and stakeholders to enhance project performance.
- Identify and mitigate project risks to minimize impact on timelines and deliverables.
- Conduct project reviews and implement lessons learned to drive continuous improvement.
- Support business development efforts by providing insights and assessments of project feasibility and potential impacts on timelines and profitability.
- Mentor and guide junior project managers in project management best practices and Nextern processes.
Requirements
QUALIFICATIONS:
- Bachelor's degree in Engineering, Business Administration, or a related field; a Master’s degree is preferred.
- A minimum of 7 years of experience in project management, particularly in the medical device or highly regulated environment.
- Proven experience managing complex projects with successful outcomes.
- PMP certification is highly preferred.
- Strong leadership skills and the ability to influence without authority.
- Exceptional communication and interpersonal skills.
- Ability to manage multiple projects simultaneously while maintaining attention to detail.
- Familiarity with FDA regulations and experience in the 510(k) process is a plus.
- Strong analytical and problem-solving skills with a focus on results.
Benefits
Nextern offers excellent benefits to fuel you in building a fulfilling life & career:
- 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
Salary Range for This Position: $140,000 - $160,000.
Nextern is an equal opportunity employer. We encourage applications from candidates of all backgrounds and experiences, and we are committed to fostering an inclusive and diverse workplace. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
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What We Do
Nextern collaborates with innovators, clinicians, and device partners to create, iterate, optimize and manufacture best-in-class medical devices. We bring an unmatched core competence in medical device product design and development through manufacturing as a leverageable asset to collaborators like you, who are focused on accelerating the commercial side of the business.
