Intellectt Inc
Engineering Project Manager Medical Devices
Intellectt Inc, Skaneateles, New York, United States, 13152
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.
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.