Engineering Project Manager - Medical Device
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CategoryEngineering
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LocationGreater Boston, Massachusetts
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TypeDirect hire
The Engineering Project Manager - Medical Device
Join this dynamic team as they make big and bold moves in Aesthetics Medical Devices
Greater Boston area
As the Engineering Project Manager you will be responsible for coordinating and managing product development projects for new product development and other R&D projects. The R&D team is developing medical devices under a Quality Management System compliant with FDA 21 CFR 820 and ISO 13485 standards. This role involves working closely with R&D engineers, Quality, Regulatory, Clinical, and Manufacturing representatives.
The Engineering Project Manager will create detailed schedules when needed, facilitate discussions to drive problem-solving, and help the team meet its timelines for design, development, verification, and validation activities. The position may be required to perform all, or a combination of the following essential responsibilities as determined by necessity.
Essential Duties and Responsibilities:
Education and/or Experience:
Physical Requirements:
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#ZR
Join this dynamic team as they make big and bold moves in Aesthetics Medical Devices
Greater Boston area
As the Engineering Project Manager you will be responsible for coordinating and managing product development projects for new product development and other R&D projects. The R&D team is developing medical devices under a Quality Management System compliant with FDA 21 CFR 820 and ISO 13485 standards. This role involves working closely with R&D engineers, Quality, Regulatory, Clinical, and Manufacturing representatives.
The Engineering Project Manager will create detailed schedules when needed, facilitate discussions to drive problem-solving, and help the team meet its timelines for design, development, verification, and validation activities. The position may be required to perform all, or a combination of the following essential responsibilities as determined by necessity.
Essential Duties and Responsibilities:
- Develop, establish and maintain detailed project schedules
- Work closely with project team members to clearly communicate deliverables and understand progress toward these deliverables
- Highlight areas of project risk and facilitate discussions to keep the project on schedule
- Help create and update project documents when needed to ensure compliance with design controls
- Assist in coordinating key project activities
- Facilitate design reviews and document reviews
- Facilitate weekly project meetings, create meeting minutes, and track key action items
- Develop and maintain dashboards of milestones and other key project metrics for each project
- Review project documents for accuracy, completeness, and consistency
- Facilitate document routing and approval process using PLM system (Arena)
- Drive process improvements and best practices related to Project Management, Design Control, and Change Control
- Ensure product development activities are in accordance with our quality management system and with our development processes.
- Other duties as assigned.
Education and/or Experience:
- Bachelor’s Degree in an engineering discipline
- At least 5 years of project management experience required in medical device industry
- Working knowledge, understanding and experience working within a Quality Management System compliant with 21 CFR 820, ISO 13485:2016, and ISO 14971 processes
- Expertise with design control, verification, and validation
- Proficiency with Microsoft Office suite; familiarity with Arena desired
- Proficiency in Project Management software such as Microsoft Project or Smartsheet
- Be driven, energetic, with high personal integrity
- Possess effective written and verbal communication, presentation, facilitation and project management skills
- Able to manage multiple priorities and execute on time
- Possess effective leadership skills; able to lead, motivate and inspire others
- Demonstrated ability to work cross-functionally to solve problems and resolve conflicts
- Strong interpersonal, analytical, organizational and leadership skills, training, and the ability to stay abreast of company products and generally accepted medical practices related to products and procedural area.
- Excellent written and verbal communication and presentation skills.
- Ability to present and effectively communicate complex clinical and technical data to the audiences of various backgrounds and knowledge levels.
- Understanding of requirements for worldwide commercialization of new medical devices
- Proven problem-solving capabilities and analytical skills
- Previous experience in the development of products in the dermatology or plastic surgery field, and medical adhesives and dressings is a plus
- Ability to successfully manage multiple time constrained projects simultaneously.
Physical Requirements:
- Prolonged periods of sitting at a desk and working on a computer
- Must be able to lift up-to 50 pounds at times
- Must be able to access and navigate each department at the organization’s facility
#LI-JJ1
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