Engineering Project Manager - Medical Devices

Job Summary :

Lead cross-functional teams in complex engineering assignments, ensuring compliance with medical device regulations and effective project execution. This role requires a strong focus on project management, collaboration, and problem-solving across traditional product lines.

Primary Responsibilities

Independently plan, execute, and direct cross-functional engineering projects, adapting standard engineering principles to develop innovative solutions.

Manage projects consisting of cross-functional teams (including but not limited to regulatory, risk management, quality, technical communications, and supplier quality)

Oversee all financial aspects of product development, including capital expenditures and cross-functional expenses.

Identify and resolve complex problems, developing new solutions as needed for project roadblocks

Knowledge

Medical Device Regulations : In-depth understanding of FDA regulations, ISO standards, and other relevant guidelines governing medical device labeling and compliance.

Project Management Methodologies : Familiarity with project management frameworks (e.g., Agile, Waterfall) and tools (e.g., Gantt charts, project management software).

Engineering Principles : Strong foundation in engineering principles relevant to medical device design and development.

Quality Management Systems (QMS) : Knowledge of QMS practices and documentation requirements.

Cross-Functional Team Dynamics : Understanding of the roles and responsibilities of various departments involved in medical device development.

Skills

Project Management Skills : Proven ability to manage multiple projects simultaneously, ensuring timely delivery within budget.

Analytical Skills : Strong analytical and problem-solving skills to identify issues and develop effective solutions.

Communication Skills : Excellent verbal and written communication skills for diverse audiences.

Leadership Skills : Ability to lead and motivate cross-functional teams.

Attention to Detail : Meticulous attention to detail in reviewing labeling documentation.

Abilities

Independent Judgment : Ability to make informed decisions in evaluating engineering techniques.

Adaptability : Flexibility to adapt to changing project requirements and industry trends.

Time Management : Strong organizational skills with effective prioritization.

Interpersonal Skills : Ability to build and maintain positive working relationships.

Continuous Learning : Commitment to staying current with industry developments.

Qualifications

Bachelor's degree in Engineering or a related field.

8-10 years of relevant experience in project management, with a focus on medical devices.

2-5 years of experience in matrix management.

Thorough, up-to-date knowledge of multiple engineering disciplines.