Principal Systems Engineer

Additional Location(s): N/A

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At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing - whatever your ambitions.

About the role:

We are seeking an experienced Principal Systems Engineer to join the Boston Scientific Neuromodulation R&D team. As a technical contributor and leader, you will play a critical role in developing neuromodulation systems and platform from concept to product launch. The Systems Engineer considers both the business and the technical needs of all customers with the goal of providing a quality product that meets the user needs. You will work closely with cross-functional teams, balancing user needs, market opportunity, and business requirements. In this role, you will lead engineering efforts to develop quality, complex medical device systems such as implantable products, Electronic Medical Equipment (EME), combination medical devices, and/or software only products, etc., for market leading differentiation and segment growth on pain and brain franchises.

Your responsibilities will include:

• Work with all stakeholders 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, and system interface requirements to define the system as a whole and all associated sub-systems.

• Support system architecture and design of new or next generation technologies/products (implantable & connected platform eco-systems) in collaboration with technical and cross-functional core teams and stakeholders.

• Translate high-level customer, business & manufacturing needs into technical requirements.

• Ensure effective development and support of hardware, mechanical, electrode/lead and software systems and associated interfaces.

• Act as an R&D representative on cross-functional deliverables.

• Identify technical risks, develop risk burndown plans, and implement phased system integration approaches to mitigate risk.

• Support special studies on subjects such as improving system quality, usability, system partitioning, trade off assessments etc. by researching and analyzing options for implementation.

• Analyzes system requirements to determine testability, completeness and support system test development, systems characterization and build traceability.

• Contribute to system risk assessment activities, Use/Design FMEA's activities.

• Create and support documentation as part of the Product Development Process (PDP) and Quality Management System.

• Drive mechanisms for detailed project planning, tracking, and issue identification.

• Provides leadership role on championing functional best practices and problem solving across functions/divisions and disciplines via internal/external experts to resolve difficult challenges.

• Builds Systems Engineering capability by mentoring engineers in engineering activities/methodologies and domain knowledge.

• 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:

• BS or MS in electrical engineering, Computer Science, Biomedical Engineering or related field

• 10+ years of experience with product development activities, preferred in a regulated environment.

• Experience with requirements authoring, systems design, trade-off analysis and verification.

• Knowledge of Software and System Architectures and design principles.

• Experience using configuration management, test management, requirements management, and issue tracking systems.

• Ability to lead teams through a structured approach to solving complex technical problems.

• Strong knowledge of Design Controls & Risk Management practices

• Strong personal credibility & excellent communication skills

Preferred qualifications:

• At least 5 years of experience leading product development teams in a Medical Regulated Environment.

• Experience in building and modifying System Architectures, Systems Requirements, Systems Design for implantable medical devices and connected platform eco-systems.

• Knowledgeable in Human Factors and Usability Engineering processes as part of regulated product development.

• Demonstrated ability to interact with and influence key stakeholders both internal and external to the organization.

• Experience dealing with regulatory questions from FDA, BSI, TUV

The anticipated annualized base pay range this full time position working at this location will be from $100,700 to $191,300, plus annual bonus target (subject to plan eligibility and other requirements) and the value of core and optional employee benefits being offered at Boston Scientific (BSC), which can be reviewed at www.bscbenefitsconnect.com. At BSC, it is not typical for an individual to be hired near the bottom or top of the pay range. BSC considers various factors in determining actual compensation for this position at the expected location. Actual compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, and other relevant business or organizational needs. Actual compensation may be otherwise adjusted if the position is filled outside of the intended geographic location.

Requisition ID: 584434

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.

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most - united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do - as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn't just business, it's personal. And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.

Boston Scientific maintains a prohibited substance free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

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.

Nearest Major Market: Los Angeles

Job Segment: Biomedical Engineering, Testing, Medical Device, R&D Engineer, Systems Engineer, Engineering, Technology, Healthcare