Project \\/ Programme Manager Senior
Project \\/ Programme Manager Senior
Posted on :
22-06-2025
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1 Vacancy
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Job Description
Description:
Location: Boston or remote
Duration: 12 months extension and/or conversion possible but for an FTE offer worker must be local to Boston and be able to work 60% onsite.
Title: Medical Device/Combination Device Engineering Project Manager
We are looking for an experienced Project Manager with a strong background in medical device development - pre-filled syringes and autoinjectors are a BIG PLUS to join our device group. The successful candidate under the guidance of the project lead will manage the end-to-end development of device/combination products. The project manager will collaborate with cross functional teams within and outside of the device group. These may include but are not limited to regulatory quality packaging CMC CMOs and other functions as required by the project.
Key Responsibilities
People leadership team culture and values:
Successfully manage without authority team of cross functional members inspire and address conflicts drive for productive resolution. Acknowledge and embrace productive values contributing to successful project teams. Lead the implementation and adherence of these values.
Planning and execution
With the guidance of the project lead and collaboration of the project team facilitate the planning and execution process including resource allocation and budgets. drive to a predictive plan adhere to agreed framework and practices.
Cross-functional Collaboration:
Work closely with CMC formulation drug product teams and other cross functional teams to ensure seamless integration of device and drug components. Facilitate alignment between device development and drug lifecycle activities.
CMOs management
Serve as the primary device point of contact for external CMOs and device suppliers; oversee timelines deliverables and issue resolution.
Design Controls & Risk Management:
Ensure rigorous application of design control processes per FDA and ISO standards (e.g. ISO 13485 ISO 14971). Lead device project risk assessments and maintain robust documentation (e.g. DHF).
Regulatory Support:
Coordinate the development of documentation to support regulatory submissions including combination product sections of INDs NDAs and EU dossiers.
Project Governance:
In partnership with the DRP and project team the PM will prepare project status reports to the leadership team and governance committees.
Meeting Facilitation & Communication:
Lead device sub-team meetings manage agendas and minutes drive decision-making and issue resolution and ensure alignment across all functions.
Qualifications
Bachelors degree in engineering life sciences or related technical field (Masters preferred).
5 years of project management experience in medical device or combination product development
Strong working knowledge of combination product regulations (21 CFR Part 4) design controls and risk management principles
Excellent cross-functional collaboration skills with various functions and groups
PMP certification or equivalent preferred
Proficient in project management software (MS Project Smartsheet Jira) and communication tools
Preferred Skills
Proven experience leading development of pre-filled syringes and/or autoinjectors.
Demonstrated experience working with external CMOs and device suppliers
Experience with technology transfer and device commercialization
Familiarity with clinical supply chain and regulatory submission processes for combination products
Exposure to global regulatory pathways including FDA EMA and other international agencies
Understanding of human factors engineering and usability testing in device development
Intake notes:
- Will co-pilot a project as the PM. The team of engineers will not report to this person but will work very closely with them must be a team player able to motivate guide them in the right direction and ask challenging questions to get the project on the right track and drive for solutions.
- Must understand the benefits of following a plan and have a sense of urgency
- Strong knowledge of project management processes and tools.
- Agile experience is very important
- Minimum of 5 years of experience from combination product or medical device such as prefilled syringes or auto injectors is required.
- Minimum of 5 years of experience from the pharma industry working with cross-functional teams/groups such as CMC regulatory packaging vendors etc.
- Understanding of design controls is key.
- Engineering background strongly preferred but not required as long as they think like an engineer and have the required experience and skills above.
Interviewing:
- One 90 minute interview with 2-3 team members.
Duration: 12 months extension and/or conversion possible but for an FTE offer worker must be local to Boston and be able to work 60% onsite.
Title: Medical Device/Combination Device Engineering Project Manager
We are looking for an experienced Project Manager with a strong background in medical device development - pre-filled syringes and autoinjectors are a BIG PLUS to join our device group. The successful candidate under the guidance of the project lead will manage the end-to-end development of device/combination products. The project manager will collaborate with cross functional teams within and outside of the device group. These may include but are not limited to regulatory quality packaging CMC CMOs and other functions as required by the project.
Key Responsibilities
People leadership team culture and values:
Successfully manage without authority team of cross functional members inspire and address conflicts drive for productive resolution. Acknowledge and embrace productive values contributing to successful project teams. Lead the implementation and adherence of these values.
Planning and execution
With the guidance of the project lead and collaboration of the project team facilitate the planning and execution process including resource allocation and budgets. drive to a predictive plan adhere to agreed framework and practices.
Cross-functional Collaboration:
Work closely with CMC formulation drug product teams and other cross functional teams to ensure seamless integration of device and drug components. Facilitate alignment between device development and drug lifecycle activities.
CMOs management
Serve as the primary device point of contact for external CMOs and device suppliers; oversee timelines deliverables and issue resolution.
Design Controls & Risk Management:
Ensure rigorous application of design control processes per FDA and ISO standards (e.g. ISO 13485 ISO 14971). Lead device project risk assessments and maintain robust documentation (e.g. DHF).
Regulatory Support:
Coordinate the development of documentation to support regulatory submissions including combination product sections of INDs NDAs and EU dossiers.
Project Governance:
In partnership with the DRP and project team the PM will prepare project status reports to the leadership team and governance committees.
Meeting Facilitation & Communication:
Lead device sub-team meetings manage agendas and minutes drive decision-making and issue resolution and ensure alignment across all functions.
Qualifications
Bachelors degree in engineering life sciences or related technical field (Masters preferred).
5 years of project management experience in medical device or combination product development
Strong working knowledge of combination product regulations (21 CFR Part 4) design controls and risk management principles
Excellent cross-functional collaboration skills with various functions and groups
PMP certification or equivalent preferred
Proficient in project management software (MS Project Smartsheet Jira) and communication tools
Preferred Skills
Proven experience leading development of pre-filled syringes and/or autoinjectors.
Demonstrated experience working with external CMOs and device suppliers
Experience with technology transfer and device commercialization
Familiarity with clinical supply chain and regulatory submission processes for combination products
Exposure to global regulatory pathways including FDA EMA and other international agencies
Understanding of human factors engineering and usability testing in device development
Intake notes:
- Will co-pilot a project as the PM. The team of engineers will not report to this person but will work very closely with them must be a team player able to motivate guide them in the right direction and ask challenging questions to get the project on the right track and drive for solutions.
- Must understand the benefits of following a plan and have a sense of urgency
- Strong knowledge of project management processes and tools.
- Agile experience is very important
- Minimum of 5 years of experience from combination product or medical device such as prefilled syringes or auto injectors is required.
- Minimum of 5 years of experience from the pharma industry working with cross-functional teams/groups such as CMC regulatory packaging vendors etc.
- Understanding of design controls is key.
- Engineering background strongly preferred but not required as long as they think like an engineer and have the required experience and skills above.
Interviewing:
- One 90 minute interview with 2-3 team members.
Additional Details
- Managers Requested Bill Rate : (No Value)
- Does the position allow for the worker to be virtual/remote : No
- Critical Position : No
- Career Level : F
- External Job Title : (No Value)
Employment Type
Full Time
Key Skills
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