Exact Sciences Corporation

Senior Systems Engineer

Job Locations US-CA-Redwood City | US-Remote
Req No.
2021-8787
Category
Research & Development
Type
Regular Full-Time

Summary of Major Responsibilities

The Senior Systems Engineer is a key problem solver and a potential core team leader to plan and lead cross-functional product development projects for In Vitro Diagnostics (IVD)medical devices from concept to manufacturing. This position will use expert technical skills, conceive, plan and lead R&D product development activities to achieve project goals. This position will leverage understanding of advanced engineering principles, advanced engineering methods, data, and judgment to influence the course of product development activities.

Essential Duties and Responsibilities

  • Apply technical expertise to lead efforts in test method development, implementation, and validation for medical device/systems.
  • Assess design feasibility and test product functionality and/or confirm product capabilities.
  • Participate in new product design and design improvements to existing products.
  • Participate in the evaluation and assessment of competitive products, processes, and/or new trends.
  • Engage with the Original Equipment Manufacturer (OEM)to provide technical oversight and guidance on evolution of the design.
  • Collaborate with hardware, software, and reagent team members to interpret and decompose voice of customer, user needs, and/or customer requirements.
  • Participate in the definition and creation of system architectures and documentation trees.
  • Responsible for requirements management activities involving creation, decomposition, and traceability of requirements.
  • Lead system integration activites during product design and Verification and Validation (V&V) phases. 
  • Lead the effort to ensure the necessary documentation for V&V activities are included in the project Design History File (DHF).
  • Utilizes Design of Experiment (DOE)as appropriate.
  • Collaborate with cross-functional teams to ensure all development activities are conducted in adherence to applicable national/international regulations, guidelines, company policies, SOPs, and industry standards.
  • Lead Human Factors Engineering/Usability Engineering tasks and activities.
  • Lead product risk management activities involving system Hazard Analysis (HA) Failure Modes and Effects Analysis (FMEA).
  • Collaborate with Quality team to establish templates and processes for the documentation of systems engineering tasks and activities.
  • Participate in the definition of key development deliverables, milestones, dependencies, risks, and mitigations as part of the Integrated Program Plan.
  • Establishes interfaces across other organizational groups.
  • Strong analytical and problem-solving skills.
  • Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
  • Support and comply with the company’s Quality Management System policies and procedures.
  • Regular and reliable attendance.
  • Ability to work nights and/or weekends.
  • Ability to lift up to 25 pounds for approximately 5% of a typical working day.
  • Ability to work seated for approximately 75% of a typical working day. Ability to work standing for approximately 25% of a typical working day.
  • Ability to comply with any applicable personal protective equipment requirements.
  • May perform repetitious actions using lab tools.
  • Ability and means to travel between Redwood City locations.
  • Ability to travel 15% of working time away from work location, may include overnight/weekend travel.

Qualifications

Minimum Qualifications

  • Bachelor's degree in Engineering, or related field.
  • 8+ years of relevant experience as a product development engineer.
  • 6+ years of experience with requirements development from user needs, design transfer functions, and risk management.
  • 6+ years of experience working on projects with cross-functional technical teams through a formal phase gate or new product development process.
  • 4+ years of experience with ISO requirements and GMP guidelines, FDA regulations, and design control.
  • Demonstrated ability to perform the Essential Duties of the position with or without accommodation.

Preferred Qualifications

  • Advanced degree (Masters / PhD).
  • Experience with next generation sequencing, immuno-histochemistry, in-situ hybridization, PCR, methylation.
  • Experience with instrument automation or scientific instrumentation.
  • Experience with system analysis, model-based system engineering, and system architecture.
  • Medical device experience.
  • Six Sigma certification.
  • Design for Six Sigma (DFSS) experience.
  • Proficiency with formal requirements management tools.

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We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company’s affirmative action program are available to any applicant or employee for inspection upon request.

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