Engineering Program Lead Regulatory & Compliance Focus (Program Manager)

Engineering Program Lead Regulatory & Compliance Focus (Program Manager)

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.

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