Engineering Project Manager - Medical Device & FDA-Regulated Products

Job Title

Job Description Required

Education:

Bachelor of Science degree in Mechanical Engineering, Biomedical Engineering, Materials Science, or a related technical discipline Preferred Certifications/Licenses:
Project Management Professional (PMP) certification Required Skills/

Qualifications:

Strong project management experience leading engineering projects in a technical environment Demonstrated ability to manage multiple projects simultaneously while balancing competing priorities and deadlines Excellent organizational, analytical, problem-solving, and decision-making skills Ability to work independently with minimal supervision while effectively collaborating with cross-functional teams Strong communication and stakeholder management skills, including the ability to present project updates and influence decision-making Experience evaluating project risks, implementing mitigation plans, and driving projects to successful completion Proficiency with project management methodologies, tools, and documentation practices Preferred Skills/

Qualifications:

4+ years of experience within the medical device industry or another highly regulated industry such as pharmaceuticals, biotechnology, aerospace, or manufacturing Experience working within FDA-regulated environments and familiarity with quality systems, design controls, risk management, and product development processes Knowledge of engineering change management, validation processes, and product lifecycle management

Primary Responsibilities:

Lead multiple concurrent engineering projects from initiation through completion, ensuring alignment with business objectives, quality standards, and regulatory requirements Develop comprehensive project plans, including scope, schedules, resource allocations, budgets, risk assessments, and communication strategies Monitor project performance against established milestones, deliverables, timelines, and budgets, proactively identifying risks and implementing mitigation strategies Coordinate and prioritize project activities across engineering teams and cross-functional departments to optimize resource utilization and meet project deadlines Evaluate, review, and approve project changes that may significantly impact project scope, timelines, budgets, or technical requirements Facilitate project meetings, provide status updates to stakeholders and leadership, and maintain clear documentation of project progress and decisions Identify operational challenges, technical obstacles, and process inefficiencies, driving resolution efforts to minimize delays and ensure successful project execution Collaborate closely with engineering, manufacturing, quality, regulatory affairs, supply chain, and operations teams to ensure project deliverables meet organizational and customer expectations Manage relationships with external vendors, consultants, contractors, and suppliers, ensuring performance standards, deliverables, and contractual obligations are met Support engineering process improvements and continuous improvement initiatives to enhance project execution, efficiency, and product quality Ensure all project activities comply with applicable regulatory standards, industry requirements, and company quality management systems

** Only those lawfully authorized to work in the designated country associated with the position will be considered.**

** Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client's business needs and requirements.**