USA Engineering Project Manager III

Hybrid
9:00am-5:00pm

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
Bachelors 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.
Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.