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Intellectt Inc

Project Manager – Medical Devices

Intellectt Inc, Skaneateles, New York, United States

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Recruiting Team Lead | Talent Acquisition Specialist | Driving Strategic Hiring Across Diverse Domains (IT, Medical Devices, Automobile… 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.

Seniority level Mid-Senior level

Employment type Contract

Job function Project Management

Industries Medical Equipment Manufacturing

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