Summary:

The Senior Systems Engineer is a key problem solver and a potential team leader to lead cross-functional workstreams and plan product development activities for projects for In Vitro Diagnostics (IVD) medical devices from concept to manufacturing. This position will use expert technical skills, conceive, plan, and participate in leading 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.

Location : REMOTE

Duties & Responsibilities

• Apply technical expertise to lead or support efforts in planning and executing system-level product development activities for medical device/systems.
• Assess design feasibility and product functionality from a system-level perspective and/or confirm product capabilities.
• Participate in new product design and design improvements to existing products.
• Oversee and drive to completion system improvement projects including system design changes, cost reductions and system optimizations.
• Participate in the evaluation and assessment of competitive products, processes, and/or new trends.
• Participate in troubleshooting activities as necessary to determine the root cause for failures as well as identify and verify corrective actions
• Engage with the Original Equipment Manufacturer (OEM) to provide technical oversight and guidance on evolution of the design and work with vendors to resolve manufacturing and design issues.
• Collaborate with hardware, software, and reagent development scientists 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 the effort to ensure the necessary documentation for V&V activities are included in the project Design History File (DHF).
• 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.
• Support Human Factors Engineering/Usability Engineering tasks and activities.
• Participate in planning and executing product risk management activities involving system Hazard Analysis (HA) and 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 Design and Development Plan.
• Establishes interfaces across other organizational groups.
• 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.

Skills and qualifications

• Bachelor's degree in Engineering, or related field as outlined in the duties & responsibilities.
• Advanced degree (Masters / PhD), preferred.
• 7 years of relevant experience as a product development engineer.
• 5 years of experience with requirements development from stakeholder needs, design transfer functions, and risk management.
• 5 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.
• Experience with immunohistochemistry/immunofluorescence, H&E staining, general clinical lab workflows, preferred.
• Experience with instrument automation or scientific instrumentation.
• Experience with system analysis, model-based system engineering, and system architecture.
• Six Sigma certification/experience desired.
• Design for Six Sigma (DFSS) certification/experience desired.
• Proficiency with common requirements management tools, preferred
• Demonstrated ability to perform the essential duties of the position with or without accommodation.
• Ability to work as part of a team.

Travel

• Potential for future travel is 10-15% to work with key partners and internal colleagues.

Akoya Biosciences, Inc. proudly affords equal employment opportunity to all qualified persons regardless of race, color, religious creed, national origin, age, military status, sexual orientation,