R&d Project Manager - Billerica, United States - Jacaranda Consulting Inc.

Description

• Develop detailed project plans outlining timelines, milestones, resource requirements, and deliverables while maintaining good design control practices.
• Coordinate crossfunctional 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.

• 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.

• 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).

• 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.

• 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.

• 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
• 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 fastpaced environment.
• Strong technical background with expertise in engineering principles and product development methodologies.

• 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.

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

• Do you have experience with design controls for medical devices, including FDA regulations (e.g., 21 CFR Part 820) and ISO standards (e.g., ISO 13485)?

• Bachelor's (preferred)

• Project Management of