job summary: Job Summary
Responsible to provide systems level technical expertise in a cross functional product development environment. In this highly visible and important role, you will lead the system level design of products from concept through design/verification, launch and commercialization support. Qualifications Education
- Minimum of BS in Engineering discipline. Biomedical Engineering degree a plus.
- Minimum of 8 years' experience in a product development role, with at least 3 years of demonstrated hands-on experience in the following:
- Translating user needs into system level specs and architecture.
- Development, execution and reporting of engineering verification and validation protocols.
- Development of complex software controlled electro-mechanical energy-based systems.
- Experience working in a capital equipment Class II Medical Device design and development environment
- High level of familiarity with FDA QMS, ISO13485 Quality Systems, IEC 60601-1 System Safety, IEC 62304 Software Development and ISO 14971 Risk Management.
- Seasoned technical leader with strong organizational and interpersonal skills
- Able to adapt communication style to resonate with intended audience
- Ability to see challenges as opportunities.
- Perseveres in the face of technical or interpersonal challenge; thrives on finding solutions
- Coaches and motivates others to find solutions rather telling them what to do
- Proficient problem-solving skills
- Generates high-quality work products and demonstrates good design practices.
- Demonstrates a consistent and gut-level sense of urgency, but remains calm under pressure.
location: Westford, Massachusetts
job type: Permanent
salary: $100,000 - 150,000 per year
work hours: 8am to 5pm
The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
- Collaborate with Program Management and Marketing to collect information from cross functional stake holders (Engineering, Marketing, Operations, Quality, Regulatory, Clinical, Service) to define user needs for new product concepts.
- Translate high level user needs into Product Requirement Specifications and architecture plans that will serve as foundations for the engineering team (electrical, software, mechanical, optics).
- Lead the creation of verification and validation protocols. Work with project team to assure execution of plans, mitigation of test failures or required protocol deviations. Ultimately release the final product verification and validation reports.
- Assure product objectives are met in the areas of functionality, product quality, reliability, serviceability, manufacturability, compliance, and cost.
- Key deliverables include Product Requirement spec, traceability, system architecture, FMEA, system verification and validation, and ongoing technical support to operations and service.
- Work with development team to create technical schedule & milestones, while working with Program Management to keep overall project on time and budget
- Identify and mitigate constraints and trade-offs relative to product requirements.
- Work with hardware and software engineering to assure seamless system integration.
- Effectively work with operations, test engineering, quality and service teams to set and achieve DFM and DFS goals.
- Manage the document configuration management process (pre-launch BOM, family tree, change requests and rev control, proto-part traceability, design freeze)
- Organize and conduct system level design reviews
- Work with Program Management to effectively transfer new products from Engineering to Operations
- Collaborate with engineering team and operations during material procurement phases for prototypes and pilot runs
- Lead engineering support activities for post launch CIP opportunities
- Work with Program Manager and Engineering to create and maintain the DHF to assure compliance with company, FDA and ISO design control requirements
- Adhere to defined development processes and procedures.
- Embody and deliver the "Exceptional Everyday"
- Experience level: Experienced
- Minimum 8 years of experience
- Education: Bachelors
- Medical Device (4 years of experience is required)
- FDA QMS (4 years of experience is preferred)
- ISO13485 (4 years of experience is preferred)
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.