Project Manager Medical Devices

ob Title: Senior Project Engineer / Engineering Project Lead
Location: Hybrid
Schedule: 9:00 AM – 5:00 PMJob SummaryLead and manage cross-functional teams on complex engineering assignments, ensuring full compliance with medical device regulations and standards. The role emphasizes project management excellence, cross-functional collaboration, and innovative problem-solving across traditional and new product lines.Primary Responsibilities

• Independently plan, execute, and direct engineering projects, adapting established principles to develop innovative technical solutions.
• Lead cross-functional teams, including regulatory, risk management, quality, technical communications, and supplier quality functions.
• Oversee all financial aspects of product development, including capital expenditures and cross-functional budget management.
• Identify, analyze, and resolve complex project and technical challenges, developing new methodologies where needed.
• Ensure project execution aligns with company goals, timelines, and compliance standards.

Knowledge Requirements

• Medical Device Regulations: In-depth understanding of FDA regulations, ISO standards, and other relevant medical device guidelines.
• Project Management Methodologies: Familiarity with Agile, Waterfall, and hybrid frameworks, as well as tools such as MS Project or equivalent.
• Engineering Principles: Strong grasp of core engineering concepts related to medical device design and development.
• Quality Management Systems (QMS): Knowledge of QMS processes, documentation, and compliance practices.
• Cross-Functional Dynamics: Understanding of cross-departmental roles within regulated product development.

Skills

• Project Management: Proven ability to manage multiple concurrent projects within time and budget constraints.
• Analytical Thinking: Strong analytical and problem-solving skills for identifying root causes and developing effective solutions.
• Communication: Excellent verbal and written communication skills tailored for diverse technical and non-technical audiences.
• Leadership: Demonstrated ability to lead and motivate cross-functional teams.
• Attention to Detail: Precision in reviewing and approving documentation and engineering deliverables.

Abilities

• Independent Decision-Making: Sound judgment in selecting and applying engineering techniques.
• Adaptability: Ability to pivot effectively in response to changing project needs or regulatory updates.
• Time Management: Strong prioritization and organizational skills.
• Interpersonal Collaboration: Build and sustain positive relationships across all organizational levels.
• Continuous Learning: Commitment to ongoing professional and technical development.

Qualifications

• Bachelor’s degree in Engineering or a related technical field.
• 8–10 years of experience in project management, with a strong focus on medical device development.
• 2–5 years of experience in matrix management environments.
• Demonstrated knowledge of multiple engineering disciplines and regulatory compliance.

Job Type: Full-time

Pay: $50.00 - $60.00 per hour

Work Location: In person

Salary : $50 - $60