Project Manager - Medical Devices

  • Full-time

Company Description

Boston Engineering provides product design and engineering consulting across the entire product development process. Boston Engineering applies expertise from its precision engineering, advanced R&D, and global PLM infrastructure offerings. Certified for ISO 9001 and ISO 13485, the firm serves consumer products, defense & security, medical devices, robotics, and industrial markets. Founded in 1995, Boston Engineering is headquartered in Waltham, Mass.

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Job Description

You can make a difference in the way people live and work by applying your experience and know how to our projects.

We are currently seeking a customer focused Project Manager (PM) who is a results-oriented, customer-focused leader and who has demonstrable success managing high-tech professionals in meeting challenging technical goals. Our projects range in complexity and involve some or all of our engineering disciplines which include mechanical, electrical, and software engineering; Quality and Industrial Design. The primary focus of this  project management role is Medical Device Development and will require technical fluency in system level engineering.

What will you do here? 

This PM will manage and be a technical contributor through the product development process which includes:

  • Development of requirements and specifications
  • Concept/system architecture
  • risk management
  • prototype build
  • design verification
  • introducing new products to manufacturing

How will you succeed?

You will need to have demonstrated capabilities in the following:

  • Establishing project plans and tracking scope, schedules, budgets and deliverables for multi-disciplinary Medical Device development projects
  • Systems-level engineering expertise with mechanical and electromechanical systems
  • Ability to successfully manage several project teams in a fast-paced environment
  • Ability to conduct and direct project efforts under ISO 13485 and FDA compliant design and development procedures.
  • Ability to prepare and present at project reviews which include identification of project risks and development of risk mitigation strategies and approaches
  • Ability to prepare proposals and develop estimates to support sales activities

Qualifications

  • Minimum of a BS degree in an engineering field (Electrical or Software Engineering Preferred) plus 10+ years in a project management role
  • Proficient in MS Office, MS Project, and MS Visio with excellent written & verbal communication skills
  • System level engineering skills with working knowledge of software, electrical, and mechanical tools and processes, with fluency in the development and review of requirements, specifications and design documents and conducting project under design controls
  • Demonstrated experience in new product development programs, bringing new products and new technologies successfully to market
  • Fluency in medical device development processes and regulations
  • Previous experience managing multi discipline project team
  • Excellent customer interface skills
  • Understand & practice job role in our quality management system as trained
  • Previous experience overseeing risk management activities (FMEA, HARA, etc) strongly desired
  • Previous experience in engineering services environment strongly desired
  • Previous experience drafting federal grant applications (SBIR, STTR, etc) desired
  • Must be a US Persons
  • No relocation

Additional Information

Boston Engineering offers a full employee benefit plan including matching 401K plan in an open, energetic working environment that fosters strong client relationships and an entrepreneurial team spirit.

All your information will be kept confidential according to EEO guidelines.