CAREERS
Job Title: Product Development Innovation Manager
A medical device company with headquarters in Beverly, Massachusetts, is an up-and-coming provider of innovative spinal surgery devices for use by spine surgeons around the world. Our company is driven by surgeon ingenuity that will improve patient’s quality of life. Our entrepreneurial environment places great emphasis on fostering innovation, creativity, and teamwork. Our enthusiasm is founded on an open spirit and a passion for results. Our business is built on people from different backgrounds, coming together for a common goal.
We are looking for an experienced Product Development Innovation Manager to work with a cross-functional team to design innovative surgical implants and instrumentation by performing the following duties:
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Create project plans for the development of various spine-related surgical implants and instrumentation
- Define product requirements and test methods
- Manage projects using the Innovation Process and manage internal resources and consultants that are part of the team to design and execute the project tasks
- Work directly with surgeons to conceptualize ideas for current projects and future projects/programs
- Establish and maintain the project schedules, budgets, project plans, test plans
- Support 510K submissions and release for sale with required documentation
- Identify risks and create mitigation plans
- Maintain Design History Records for projects under development
- Identify regulatory compliance requirements and create plans for meeting them
- Assist in training internal staff, sales/service reps and surgeons on the projects/programs
- Identify vendors for critical component selection
- Other duties as assigned
QUALIFICATIONS
To perform this job successfully, an individual must have the skills and experience to perform the essential duties with little or no guidance. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION AND/OR EXPERIENCE
• A Bachelors degree in Mechanical Engineering, Biomedical Engineering or equivalent and 7 to 15 years of product design experience, including structural analysis, tolerance analysis, design for manufacturing and assembly and knowledge of basic ergonomics
• 3 to 5 years of project management experience required
• MBA or PM certification preferred
• Proficiency with SolidWorks 2009 or later CAD experience is essential
• Cosmos experience a plus
• Experience with 21 CFR 820, ISO 13485 and ISO14971 desirable
• Experience in a manufacturing environment desirable
SKILLS/ABILITIES
• Strong oral and written communication skills
• Well-developed organizational skills
• Attention to detail
• Proficiency with relevant software applications is essential
• Creative problem-solving skills
• The ability to work in an extremely fast paced and dynamic environment
• Strong interpersonal skills and the ability to work both independently and collaboratively as part of a team is essential
• A sensitivity to customer service
• Ability to maintain a high degree of flexibility across all areas of responsibility required
SUPERVISORY RESPONSIBILITIES
• Engineers and Designers
TRAVEL
• 15-20%
*We offer tremendous room for advancement and income potential.
All submissions will be held in the strictest confidence. This position is being sought after for immediate hire.
SpineFrontier is an Equal Opportunity Employer.
Please submit your resume and cover letter to mycareers@spinefrontier.com