Principal Systems Engineer

Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world—from the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better.

Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries, extending our reach to billions of potential customers across the globe.

Objective:
The R&D Lead Principal Systems Engineer acts as the lead R&D representative for large, multi-disciplinary, surgical equipment platform development teams. The role is established to provide centralized technical leadership, strategic inputs, and a consolidated voice for the design and development sub-team during initial development, launch, and post-launch monitoring as part of the product life cycle management process.

They serve as the official representative of Design and Development sub-teams on cross-functional, new product introduction (NPI), Strategy Boards. In this capacity, they provide regular updates to the program Strategy Board, using data and analysis to demonstrate design and development process execution status, to identify execution risks, and to establish alignment behind execution plans, including resourcing and prioritization. They communicate and defend technical recommendations of the design and development team relative to product features, performance targets, system scope, and program stage gate decisions. They offer strategic and planning support to other NPI sub-team leaders on the NPI Strategy Board.

Within the Design and Development team, the R&D Lead Principal Engineer promotes a strong culture of collaboration and teamwork. They schedule and moderate technical and strategic meetings to address issues of disagreement among other leading contributors or to select the best direction when faced with multiple options. They integrate the inputs and perspectives from project management and cross-functional contributors within the design and development sub-team to develop a team position and they cultivate alignment to the position. They escalate critical matters to functional leadership when teams are unable to reach consensus.

As a tactical leader within the systems engineering function, the R&D Lead Principal System Engineer further provides system-level oversight and high-level management of all design control, risk management, and usability engineering deliverables.

They offer high-level individual contributions as an author and approver of planning documents, architecture specifications, design input documents, verification and validation plan and report documents, risk analysis documents, traceability reports and other system-related deliverables. They contribute technical expertise, collaboration, guidance, and direction to other systems engineers.

Responsibilities:

• Strategic Leadership Responsibilities – Representation of Design & Development Tactical Sub-Teams via Membership on the Project Strategy Board.
• Provide the consolidated strategic perspective for the R&D function relative to product-focused decisions including: feature set scoping, preferred design concepts, requirement tradeoffs/design optimization, technology implementation decisions, and associated cost and timing concerns.
• Assess/Demonstrate that design and development activities are fulfilling relevant commercial goals and design for six sigma requirements at applicable product development cycle stage gates.
• Propose directives (e.g. go/no go/rework/hold) relative to continued commercialization of the selected product detailed design at associated gate review meetings.
• Communicate relevant information to the NPI Governance Board at major program stage gates to facilitate effective decision making.
• Assess/Demonstrate, via the Design History File, that all Medical Design Control process requirements have been addressed by the Design and Development process in accordance with the Design and Development plan.
• Assess/Demonstrate, via the Device Master Record, that relevant production specifications have been formally released to appropriate development lifecycle states at appropriate project review gate junctures in accordance with the Design and Development plan.
• Assess/Demonstrate, via the Risk Management File, that all relevant Risk Management Process requirements are fulfilled at appropriate gate reviews per both the Risk Management process SOP and the product/system specific Risk Management plan.
• Assess/Demonstrate, via the Usability Engineering File, that all relevant Usability Engineering Process requirements are fulfilled at appropriate gate reviews per both the usability engineering process SOP and the product/system specific usability engineering plan.
• Communicate the R&D functional perspective for strategic and gate approval decisions for other product development sub-team deliverables including: supply chain and manufacturing process development; global registration; product positioning and commercial launch, scientific/industry publications; intellectual property; and clinical studies.
• Assess and communicate appropriate information concerning design and development execution risks, competitive threats, resource risks, disruptive technology advancements, and related aspects with potential adverse effect on the viability of the product development effort.
• Communicate relevant information to facilitate effective planning and monitoring at the program level by identifying and tracking key interdependencies and shared deliverables between the design and development process and other product development sub-processes (e.g. registration, supply chain development).
• Identify and communicate the R&D strategic perspective relative to systems and tools that will be used throughout the product life cycle to manage design control (DHF/DMR), risk management, and usability engineering documents and specifications.
• Identify and communicate systemic obstacles and threats to the execution of the Design and Development plan.

Tactical System Engineering Responsibilities:

• Lead / facilitate the integration of microsurgical system assemblies and components.
• Establish/maintain the product architecture and interface schemes for the individual equipment, durable accessories, single use surgical packs, and single use devices that comprise an ophthalmic surgical system.
• Establish/maintain the structure for the hierarchy of design input requirements, drive the creation and approval of system-level requirements, and oversee execution of requirements development for subsystems based on the specified requirements architecture.
• Lead the development of architectural specifications for the design outputs; ensure that traceability between requirements, architectural specifications and detailed design outputs is established and maintained.
• Establish/maintain the Design History File, Risk Management File, and Usability Engineering File for new system development projects.
• Drive the development of system-level and aggregated risk management documentation including harms-based risk assessments, system failure analyses, verification of implementation/effectiveness traceability reports, and risk management summary reports.
• Ensure issues are logged and tracked to resolution in the ARAS Product Lifecycle Management (PLM) problem reporting system.
• Establish/maintain the traceability between Design Inputs, Outputs, and Verification/Validation reports.
• Lead / facilitate the development of outside supplier technical specifications.
• Assist the cognizant Project Manager in the development of the associated third party development Statements of Work (SOWs).
• Lead the coordination of preparation of formal Verification & Validation Testing of surgical systems and associated subsystems, accessories and surgical packs.
• Plan for and drive overall system reliability analysis and testing.
• Analyze status and define priorities for individual contributors using data harvested from the ARAS PLM database.
• Provide training, offer direct assistance, and engage technical support as required, to facilitate effective data integration and utilization of ARAS PLM tools for system development.

Requirements:

BS or higher engineering degree in systems engineering, mechanical engineering, biomedical engineering, electrical engineering, computer engineering/computer science or other related engineering discipline.

10 plus years of professional design engineering experience involving the design and development of complex electromechanical systems and/or system accessories with demonstrated technical leadership of cross-functional teams.

Broad understanding of medical device design and development processes, workflows, and tools as well as manufacturing methods for mechanical hardware, electronics, cabling, control algorithms, firmware, and embedded software.

Applied expertise in the execution of design and development projects conforming to applicable process standards and regulations for Medical Device Design Controls (21 CFR Ch1, H, 820.30/ISO 13485/EU MDR), Risk Management (EN ISO 14971), and Usability Engineering (ANSI/AAMI/IEC 62366).

Application of medical device product standards and design requirements management.

Strong systems engineering and architecting skills.

FMEA/Fault Tree Analysis.

Command use of Medical Device Documentation Control and Change Management Systems.

Good relationship building skills and technical team leadership.

Excellent oral and written communication skills.

Strong data analysis capabilities with clear and effective presentation of results.

Cross-discipline and cross-functional collaboration.

High attention to detail and strong organizational skills.

Ability to successfully persuade and influence others.

Microsoft Excel, Word, PowerPoint.

Preferred Qualifications:

Aras Innovator PLM.

Design for Six Sigma (DFSS).

Medical Device Audits – Design Controls & Risk Management.

Quality Function Deployment (QFD).

Analytical Hierarchy Process (AHP).

Minitab or equivalent statistical analysis software.

SolidWorks PDM.

Project Management Training/Microsoft Project.

Problem Solving Tools – 5 Why, DMAIC, TRIZ or Equivalent.

ERPLx, SAP, or other ERP Systems.

Microsoft BI.

AI Tools.

D2 Documentum.

Kintana.

Catsweb.

• Twelve or more years of medical device product development experience involving: equipment and sterile single-use accessory devices; 5 or more years of systems engineering or multi-disciplinary technical leadership experience; and 2 or more years of experience with ophthalmic surgical devices.

We offer competitive salary & excellent benefits including:

Medical, Dental, Eye Health, Disability and Life Insurance begins on your hire date.

401K Plan with company match and ongoing company contribution.

Paid time off – vacation (3 weeks - prorated upon hire), floating holidays and sick time.

Employee Stock Purchase Plan with company match.

Employee Incentive Bonus.

Tuition Reimbursement (select degrees).

Ongoing performance feedback and annual compensation review.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.

Our Benefit Programs:

Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.