Medical Device/Combination Device Engineering Project Manager

Medical Device/Combination Device Engineering Project Manager

Job Title

:

Medical Device/Combination Device Engineering Project Manager

Location

: Boston, MA, 02210

Duration :

12 months Contract-possible to extend

Shift Details : 1st

Pay Range : $65/hr. - $72/hr.

Job Description

:

Duration: 12 months, extension and/or conversion possible, but for an FTE offer, w

orker

must be local to Boston and be able to work 60% onsite.

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

Bachelor's degree in engineering, life sciences, or related technical field (Master's 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 principle

s

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

In

take 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

Employers have access to artificial intelligence language tools (AI) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

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Dice Id:

91082005

Position Id:

2025-24155