Project Manager (R&D / Regulatory) at FIRSTMILE - A Meraqui Company in Danvers, Massachusetts

Posted in Other about 2 hours ago.

Type: full-time





Job Description:

Title : Project Management

Location: Danvers

Plant Location: 37A Cherry Hill Dr, Danvers, MA, US

Location: MN

Minneapolis, MN 55432-5604

USA

JD:

Provide technical leadership and take ownership of critical technical tasks in the execution of new product development catheter projects.
• Liaise with key opinion leaders to develop a deep understanding of the disease

state, gather user needs; and articulate throughout the team.
• Translate needs requirements into technical specifications.
• Foster a culture of creativity; generate creative product solutions to address

unmet needs.
• Provide leadership to the team in the development of test models for prototype

performance evaluations, building and testing of prototypes, test data analysis

and interpretation, component and finished device assembly

drawings/specifications, product materials selection, and process development.

Hands-on approach where appropriate, leading critical activities by example.
• Identify and manage key technical risks and appropriate mitigations throughout

the product lifecycle.
• Write and/or review procedures, protocols, specifications, and reports.
• Identify and recommend optimal solution(s) for commercialization.
• Interface with physicians; evaluate and assess user techniques and develop

product training materials.
• Identify and support development of processes for new catheter developments.
• Support generation of Intellectual Property by filing new ideas and drafting

patents as required. Encourage and support idea generation and filing across the

engineering groups on site.

Develop detailed technical project goals, plans and budget.
• Identify critical project tasks, define project strategy, and set team priorities.
• Identify and manage key program risks.
• Manage direct team and across functions to deliver on performance, time and cost

targets.
• Report progress across the organisation.
• Leverage and liaise with external resources to achieve project goals.
• Manage project in accordance with quality system - take ownership of design

history file and lead design reviews.
• Develop marketing materials (presentations/videos/demos).
• Attend external meetings with key opinion leaders to present the client product portfolio and gain feedback on new product development.
• Perform other duties as assigned or required.

Educational Background

Bachelor's Degree: Typically in project management, business administration, engineering, or a related field , Lifesciences.

Master's Degree: Can be advantageous, especially for senior positions.

Experience

Project Management Experience: At least 3-5 years of experience in managing projects.

Industry-Specific Experience: Relevant experience in the specific industry or field.

Skills

Communication: Excellent verbal and written communication skills.

Leadership: Strong leadership and motivational skills.

Organizational Skills: Ability to manage time and resources efficiently.

Problem-Solving: Strong analytical and problem-solving abilities.

Decision-Making: Effective decision-making skills.

Technical Skills: Proficiency in project management software and tools, such as MS Project, JIRA, or Trello.

Certifications

Project Management Professional (PMP)

Certified ScrumMaster (CSM)

Certified Associate in Project Management (CAPM)

Lean Six Sigma Certification
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