Engineering Program Lead – Regulatory & Compliance Focus (Program Manager)Location: Onsite at Rochester, New York OR at Skaneateles, NYType of Hire: Contract/ C2H - ContractJob Description: 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.
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