Program Manager

  • location: West Boxford, MA
  • type: Permanent
  • salary: $100,000 - $140,000 per year

job description

Program Manager

job summary:
  • Lead projects, from product concept to commercialization, ensuring required resources are applied to achieve objectives in the areas of on-time delivery, product cost, and quality.
  • Establish and lead a cross-functional team from R&D, Regulatory, Clinical, Quality, Marketing through New Product Development (NPD) process. Plan, track, and publish status of required project deliverables.
  • Establish and drive the creation of Product Development Documents by partnering with customer-facing functions to detail the user needs, marketing and regulatory claims, and requirements, forming the basis for new product development.
  • Interface with external partners and OEMs to enable distribution of technology/ products through
  • Interface with Operations and key suppliers throughout the NPD process, driving design for manufacturability and production ramp up.
  • Lead project teams with a high level of urgency, driving alignment and decisions cross-functionally across the organization.
  • Project cost and resource tracking; Product cost tracking.
  • Track and report any product changes/revisions and drive the changes through the ECO process.
  • Assure compliance with worldwide regional registration requirements.
  • Responsible for creating and presenting Executive updates
  • Participate in Product Lifecycle Roadmap development and maintenance with business teams to assure alignment with resources and priorities.
  • Experience developing medical devices in an ISO and FDA regulated environment
  • Behavioral and Interpersonal:
  • Proven experience as a Project Manager/Leader bringing products from concept to launch on time and on schedule.
  • leadership skills and cooperative positive attitude is a must.
  • Extremely results driven.
  • Excellent organizational and planning skills. Proven ability to multi-task.
  • Uses independent judgment to anticipate and assess project/ technical risks, develops risk mitigations, and drives resolution.
  • Proven experience developing processes that improve efficiency, quality, and cost of product development.
  • Experience working on complex, multidisciplinary capital equipment projects.
  • Proven experience serving as an ambassador internally and externally.
  • Confident, with ability to influence at all levels in an organization; excellent negotiation and collaboration skills
  • Excellent interpersonal & communication skills, both written & verbal; excellent presentation skills.


Supervisory Responsibility:

  • Cross functional teams
  • Dotted line to multiple technical disciplines.


Sphere of Influence: Ability to influence key organizational personnel without direct reporting responsibility.

Education and Experience Requirements:

  • Technical or business degree required. Advanced degree is a plus.
  • Minimum 10 years in a product development environment
  • Minimum 5 years' experience leading cross functional product development projects from concept to commercial launch and sustaining
  • Minimum 3 years' experience in a medical device or equivalently controlled environment.
  • Experience with development of capital energy-based equipment.
  • experience with MS project (or equivalent), Project Planning tools, PLM tools, and familiarity with ERP systems.
  • Experience with sterile disposable medical devices, is a plus.
  • Familiar with FDA/QSR, ISO/MDR and applicable industry standards.
  • Familiar with DOE, DFM, LEAN and Design for 6 Sigma techniques is a plus.
 
location: Westford, Massachusetts
job type: Permanent
salary: $100,000 - 140,000 per year
work hours: 8am to 6pm
education: Bachelors
 
responsibilities:
  • Lead projects, from product concept to commercialization, ensuring required resources are applied to achieve objectives in the areas of on-time delivery, product cost, and quality.
  • Establish and lead a cross-functional team from R&D, Regulatory, Clinical, Quality, Marketing through New Product Development (NPD) process. Plan, track, and publish status of required project deliverables.
  • Establish and drive the creation of Product Development Documents by partnering with customer-facing functions to detail the user needs, marketing and regulatory claims, and requirements, forming the basis for new product development.
  • Interface with external partners and OEMs to enable distribution of technology/ products through Cynosure.
  • Interface with Operations and key suppliers throughout the NPD process, driving design for manufacturability and production ramp up.
  • Lead project teams with a high level of urgency, driving alignment and decisions cross-functionally across the organization.
  • Project cost and resource tracking; Product cost tracking.
  • Track and report any product changes/revisions and drive the changes through the ECO process.
  • Assure compliance with worldwide regional registration requirements.
  • Responsible for creating and presenting Executive updates
  • Participate in Product Lifecycle Roadmap development and maintenance with business teams to assure alignment with resources and priorities.
  • Experience developing medical devices in an ISO and FDA regulated environment
The essential functions of this role include:

  • working in a smoke free environment
 
qualifications:
  • Experience level: Experienced
  • Minimum 10 years of experience
  • Education: Bachelors
 
skills:
  • Medical Device (10 years of experience is preferred)
  • OEM (10 years of experience is required)

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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