Stefanini Group
Details
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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.
Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
Listed salary ranges may vary based on experience, qualifications, and local market. Also, some positions may include bonuses or other incentives.
About Stefanini Group The Stefanini Group is a global provider of offshore, onshore and near shore outsourcing, IT digital consulting, systems integration, application and strategic staffing services to Fortune 1000 enterprises around the world. Our presence is in countries like Americas, Europe, Africa and Asia, and more than 400 clients across a broad spectrum of markets, including financial services, manufacturing, telecommunications, chemical services, technology, public sector, and utilities. Stefanini is a CMM level 5 company with global presence.
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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.
Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
Listed salary ranges may vary based on experience, qualifications, and local market. Also, some positions may include bonuses or other incentives.
About Stefanini Group The Stefanini Group is a global provider of offshore, onshore and near shore outsourcing, IT digital consulting, systems integration, application and strategic staffing services to Fortune 1000 enterprises around the world. Our presence is in countries like Americas, Europe, Africa and Asia, and more than 400 clients across a broad spectrum of markets, including financial services, manufacturing, telecommunications, chemical services, technology, public sector, and utilities. Stefanini is a CMM level 5 company with global presence.
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