R&D Systems Engineer

Description

The company works on healthcare innovation across medicines and medical technology, aiming for treatments that are smarter, less invasive and more personal.

It treats each employee as an individual and values their diversity, dignity and merit.

Job function: R&D product development. Sub-function: R&D software and systems engineering. Category: scientific and technology.

The Orthopaedics group develops joint reconstruction, trauma and craniomaxillofacial, sports, extremities, foot and ankle, spine, and robotics and digital surgery solutions, serving more than 6 million people a year and aiming to deliver clinical and economic value to surgeons and healthcare systems.

This role sits at the front of digital and robotic technology for orthopedic devices, covering system requirements, risk analysis for orthopedic robotic platforms and architecture review, and working closely with teams from different disciplines.

The company plans to separate Orthopaedics into a standalone company within 18 to 24 months, subject to legal requirements, consultation with works councils and employee representatives where required, regulatory approvals and other usual conditions. The new company will operate under its own name.

Responsibilities

• Manage system-level risk, including use-related risk analysis, in a tightly regulated setting.
• Work with subsystem teams to break down and pass on requirements and risks.
• Help shape design strategies, system architectures, functional diagrams and system concepts with cross-disciplinary teams.
• Take part in system development, implementation and integration to support verification, validation and launch.
• Identify, assess and communicate system requirements and risks alongside design teams across the system lifecycle.
• Work with cross-functional stakeholders to write use cases and user stories that define user needs, design requirements and system risks.
• Support requirements traceability and change impact assessments across user needs, system and subsystem requirements, and risk controls.
• Help evaluate and troubleshoot how hardware, software and subsystems interact during integration.
• Take part in system verification, validation and usability work, including writing protocols, running tests, analyzing results and documenting them.
• Help improve system workflows, usability and instructions for use.
• Support regulatory submissions.
• Carry out analyses that assess the safety and effectiveness of the system architecture.
• Prepare and present technical material that stakeholders and users at every level can understand.

Requirements

• 1-2 years of experience in new product development for medical devices.
• BS in Systems, Biomedical Engineering, Robotics or Mechatronics.
• Advanced or graduate degree in engineering (preferred).
• Experience developing orthopedic medical devices (preferred).
• Experience with surgical navigation or robotics (preferred).
• Experience with Design Controls and requirements management for medical devices.
• Experience with sustaining engineering and change management for medical devices.
• Experience running system design verification and validation testing.
• Knowledge of IEC 60601, ISO 14971, ISO 13485 and 62366.
• Experience in an operating room supporting surgeons with digital technology.
• Preferred skills: analytical reasoning, business behavior, execution focus, model-based systems engineering (MBSE), problem solving, process orientation, product design, requirements analysis, research and development, SAP Product Lifecycle Management, scripting languages, software development life cycle (SDLC), software development management, software engineering practices, software testing, systems development lifecycle (SDLC), technical writing, and being technologically savvy.

Conditions

Based in Boston, Massachusetts, USA, with a minimum of 3 days per week in the office.

Base pay range: $78,000.00 - $126,500.00.

Equal opportunity applies, and accommodations are available for applicants with disabilities.

Benefits

• Eligible for the consolidated retirement plan (pension) and savings plan (401(k)), subject to plan terms.
• Eligible for the long-term incentive program.
• Time off, subject to policy and date of hire: vacation of 120 hours per calendar year; sick time of 40 hours per calendar year, or 48 hours for employees living in Colorado and 56 hours for employees living in Washington; holiday pay including floating holidays of 13 days per calendar year; work, personal and family time of up to 40 hours per calendar year; parental leave of 480 hours within one year of the birth, adoption or foster care of a child; bereavement leave of 240 hours for an immediate family member and 40 hours for an extended family member per calendar year; caregiver leave of 80 hours in a 52-week rolling period and 10 days; volunteer leave of 32 hours per calendar year; and military spouse time off of 80 hours per calendar year.