Page Title
| Navigation Bar Placeholder |
Page Title
| Navigation Bar Placeholder |
Page Title
| Navigation Bar Placeholder |
Page Title
| Navigation Bar Placeholder |
Page Title
| Navigation Bar Placeholder |
Page Title
| Navigation Bar Placeholder |
Page Title
| Navigation Bar Placeholder |
Page Title
| Navigation Bar Placeholder |
Page Title
| Navigation Bar Placeholder |
 |
| |
 |
| |
 |
| |
 |
| |
 |
| |
 |
| |
 |
AFFORDABLE SOLUTIONS, INC.
Your Technical Staffing Specialists
Job Description
We are a developer and manufacturer of leading edge cardiac assist devices is seeking an experienced
Program Manager to manage multi-disciplinary teams in the design, development, and commercialization of
single use medical implants and/or instrumentation while successfully meeting technical, schedule, quality
and budget targets.
The ideal candidate will have worked with class III implantable devices, have strong design and materials
skills, have programs that included pre-clinical and clinical trials and have demonstrated experience with
design control spanning product definition, specification, design, verification, validation, and quality and
manufacturing.
Responsibilities include:
Leadership/Planning
- Participate in the creation of Program Proposals by defining project scope, schedule, risk assessments
and budgets.
- Work closely with senior management to establish program milestones.
- Lead a multi-disciplinary team to coordinate efforts, identify risks and focus priorities to achieve program
milestones.
- Develop and maintain annual budgets, program priorities and development goals.
- Communicate ideas and information clearly, effectively, and frequently (oral and/or written) within program
team and throughout the company.
- Present weekly program progress updates.
Management/Execution
- Manage the staff and development efforts from the prototype phase and thru commercial release.
- Apply program management techniques to ensure technical, financial and schedule success.
- Manage coordination efforts with manufacturing, quality assurance, regulatory and other internal
organizations.
- Prioritize task importance and maintain the project teams focus on critical issues.
Technical Leadership
- Possess a strong functional understanding of all aspects pertaining to the design, development and
commercialization of disposable products.
- Strong working knowledge of FDA's QSR and practical application through, design control SOP's,
verification and validation testing.
Department Contribution
- Suggest, contribute and/or champion initiatives to improve the execution of product development
processes
Skills/Requirements
Skills
BS in Engineering (Mechanical, Biomedical, or Plastics; advanced degree a plus) with 10 years practical
engineering experience, 5 years successful program management experience; medical device industry a
plus.
Previous experience is managing programs with clinical trials required.
Project Management Certificate a plus.
Six Sigma and Design for Six Sigma training a plus.
The new req needs to have experience in class 3 medical devices, implantable medical devices, and
cardiology experience
Program Manager
Position: Permanent
Shift: 1st
Location: Danvers Area
Shift: 1st
Location: Danvers Area