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.