Your responsibilities will include:
- Work with all stakeholders as appropriate to translate user needs into design requirements (e.g. hardware, software, mechanical, electrical, interface, etc.) consisting of system requirements, sub-system requirements, product/system security requirements, digital architecture, and system interface requirements to define the system as a whole and all associated sub-systems.
- Design, define, and implement system requirements to generate design inputs/outputs, associated processes and working parameters by using current systems engineering methods and technologies. May include simulations, mathematical analysis and/or system interaction analysis.
- Collaborate with Quality Engineering, Design Assurance (DQA) and technical writing staff to produce final product technical document release.
- Solves system problems by analyzing the situation and recommending corrective or alternative actions.
- Analyzes, coordinates system partitioning (i.e. hardware/software partitioning) and total system integration by using systems engineering practices.
- Conducts special studies on subjects such as improving systems engineering practices, improving system quality, subsystem partitioning, etc. by researching and analyzing options for implementation.
- Directs support personnel and project activities.
- Builds Systems Engineering capability by mentoring engineers in engineering activities/methodologies and domain knowledge.
- Analyzes and coordinates industry-based standards testing (e.g. ISO 60601) and associated validation and verification testing and develop associated test plans and procedures.
- Continuously improve processes and work methodologies (using agile/lean principles to eliminate waste) to help solve complex, interdisciplinary problems by interfacing with peers/cross-functional groups.
- Assists Regulatory with product submissions.
Required Qualifications:
- Engineering degree (EE, computer science, or biomedical) and experience driving projects and tasks to closure.
- 6+ Years of experience within the Medical Device industry with BS degree, 4+ Years with MS or PhD
Preferred Qualifications:
- Medical Device experience working with electrical and electromechanical capital equipment systems (EEG, Electrophysiology, Ablation, Thrombectomy, etc).
- Experience conducting simulations, mathematical analysis and/or system interaction analysis.
- At least 6 years of engineering experience in mixed HW/SW systems.
- Technical experience with high level requirements capture and configuration management.
- Usability engineering experience.
- Strong communications and time management abilities.
- Ability to provide technical leadership within cross-functional teams.
- Track record of independent and solution-oriented work style.
Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law.
Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.