Senior Systems Engineer

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. 

Essential Duties and Responsibilities

• 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.  This may include the following:
  • Conduct internal and external studies to evaluate new techniques, lasers, or other technologies.
  • Analyze and evaluate data from both in-house and external collaborators to document development.
  • Develop prototypes systems to be used in future evaluations.
  • Responsible for written reports, white papers, patent disclosure, and other publications as part of the development process.
  • Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
  • Exercises judgement in selecting methods, techniques and evaluation criteria for obtaining results.
• 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).
  • Where appropriate and in-line with candidate’s education and prior experience, develop and implement design solutions which address Product Requirements
• 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 live our company Values.

Qualifications 

Education
☒ Bachelor’s degree required
☒ Master’s degree preferred

Specific Area of Study: BS in an Engineering discipline. Biomedical Engineering degree a plus.

 
Experience
☒ 5 to 8 years relevant experience 

Specific Related Experience: Experience in a product development role and 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.

Skills

• 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 than 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.