We are currently seeking an R&D Project Manager with a strong engineering background for the Research & Development group within Belmont Medical Technologies. This position will be based at our Billerica, MA campus, report to the R&D Program Manager, and involve leading a mix of new product development and sustaining projects. The ideal candidate will have a proven track record of managing projects from conception (proof of concept / feasibility) to completion (design transfer), with a focus on innovation, quality, and regulatory compliance. This role offers the opportunity to lead cross-functional teams in the development of cutting-edge medical devices that positively impact patient lives and outcomes.

Duties and Responsibilities

Project Planning and Execution:

• Develop detailed project plans outlining timelines, milestones, resource requirements, and deliverables while maintaining good design control practices.
• Coordinate cross-functional teams including engineers, consultants, and external partners to ensure project objectives are met on time and within budget.
• Monitor project progress, identify potential risks (project, technical, business, etc.), and implement mitigation strategies to keep projects on track.

Technical Leadership:

• Provide technical guidance and experience throughout the product development lifecycle.
• Collaborate with R&D, marketing, quality, regulatory, and manufacturing teams to define and manage product requirements, design specifications, and performance criteria for medical devices.
• Foster a culture of innovation and continuous improvement through iterative development.

Regulatory Compliance:

• Ensure all project activities comply with relevant US/EU regulatory standards and guidelines, are well documented, and are captured in the design history file (DHF).
• Coordinate with regulatory affairs teams to prepare and submit necessary documentation for product approvals and certifications (FDA, EU MDR).

Quality Assurance:

• Conduct risk assessments and lead design reviews to identify and address potential quality issues early in the development process.
• Evaluate Engineering Change Orders (ECOs) for technical accuracy and completeness.

Stakeholder Communication:

• Serve as the primary point of contact for internal and external stakeholders regarding project status, milestones, and technical updates.
• Facilitate regular meetings and communication channels to promote collaboration and alignment across teams.

Minimum Qualifications:

• Bachelor’s degree in Engineering or related field.
• 3+ years’ experience in medical device development and/or other regulated industry.
• 1+ years’ experience in project / program management of medical device development.
• Familiarity with regulatory requirements and design controls for medical devices, including FDA regulations (e.g., 21 CFR Part 820) and ISO standards (e.g., ISO 13485).
• Excellent communication and organizational skills with the ability to effectively break down complex problems and collaborate with multidisciplinary teams and stakeholders.
• Demonstrated leadership capabilities, including the ability to motivate teams, resolve conflicts, and drive results in a fast-paced environment.
• Strong technical background with expertise in engineering principles and product development methodologies.

Preferred Qualifications:

• 5+ years' experience in medical device development and/or other highly regulated industry.
• 3+ years’ experience in project management of medical device development.
• Scrum certification or equivalent project management credentials.
• Familiarity with Jira, SmartSheet, MS Project, or equivalent project management tools.

It is the policy of Belmont Medical Technologies to provide equal employment opportunities without regard to race, color, religion, sex, national origin, age, disability, marital status, veteran status, sexual orientation, genetic information or any other protected characteristic under applicable law.

Job Type: Full-time

Pay: $100,000.00 - $145,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Referral program
• Tuition reimbursement
• Vision insurance

Experience level:

• 3 years

Schedule:

• 8 hour shift
• Monday to Friday

Experience:

• medical device: 3 years (Preferred)
• engineering project management: 1 year (Preferred)

Work Location: In person