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Systems Engineer
MOLLI Surgical – US and Canada
Locations: Central and Eastern US, Manitoba, Saskatchewan and Eastern Canada
Reports to: Project Manager
Relocation: Yes
Work authorization in Canada or USA is required
February 2022
At MOLLI Surgical, we believe healthcare needs to get simpler to get better. To achieve this, we focus on learning about the patient experience and developing new medical devices and services that help surgeons and their teams be more efficient and effective. We honour the surgical teams who have dedicated their lives to saving yours.
MOLLI Surgical has operations in the U.S. and Canada, with headquarters in Toronto, Ontario and corporate offices in Deerfield, Illinois. We are led by a commercially experienced team of cancer specialists and healthcare professionals. Founded in partnership with Sunnybrook Health Sciences Centre, we create innovative solutions by utilizing easy-to-use and effective technology to deliver a positive patient experience with clinical precision.
As a Systems Engineer at MOLLI Surgical, you will be an integral part of the engineering team and will drive the development of the next generation of products, while supporting existing products and providing system-level oversight and guidance. You will report to the Project Manager. The short term will be focused on leading the engineering team through product development to regulatory submission, with a focus on systems-level integration and risk management, ensuring our product meets the needs of care teams and patients. The medium term will involve providing leadership to transition from product development to manufacturing. You will collaborate with a cross-functional team including mechanical, electromechanical, software, quality, R&D, operations, manufacturing, and regulatory. The primary work environment will be at a desk, both remote and in-office, with some travel within Canada and the US to customer and supplier sites as permitted by regional travel restrictions and recommendations as well as institutional policies.
We’re looking for the next generation of hustlers and creators. We’re searching for candidates that possess self-confidence who know that with the right team, anything is possible. If you believe you have what it takes, MOLLI Surgical has a position for you.
The competitive application includes a cover letter describing adversities and challenges you have overcome through grit and ingenuity alongside your resume and references. Additionally, an innovation portfolio should be provided that highlights some of your fascinating projects.
Responsibilities
Apply a cross-functional/collaborative approach and systems-level thinking to planning, design, development, compliance and launch of MOLLI Surgical devices within ISO 13485, MDSAP and FDA quality systems requirements
Translate care team, patient, market and business requirements into systems requirements/design inputs and specifications
Contribute to the development of the system architecture, subsystems interfaces, interface requirements and behaviours
Plan, coordinate, and own the risk management activities (Hazard analysis, FMEA, risk mitigations, etc.)
Plan, coordinate, and lead the execution of human factors and usability testing activities (formative and summative testing)
Work with the team to develop the verification and validation (V&V) plan and support the development and execution of V&V protocols
Develop technical documentation of the product (Design History File, Device Master Records) and maintain traceability
Lead and participate in design reviews, phase reviews, post-market reviews and brainstorming sessions
Manage and coordinate external testing with testing labs (biocompatibility, sterilization, electrical safety, EMI, etc.)
Assemble and test prototypes and products
Contribute to the continuous improvement and application of systems engineering processes, best practices and tools
Provide guidance on the use and application of various medical device standards to team
Lead the design transfer to manufacturing activities and liaise with suppliers/contract manufacturers
Assist with sustaining activities such as investigating issues arising from the field (CAPAs, nonconformances, etc.)
What We’re Looking For
Bachelor degree in Engineering (Systems, Biomedical, Mechanical or equivalent)
4+ years of experience in systems engineering related role on products involving both hardware and software preferably in medical devices (or similar regulated industry)
Strong working knowledge of risk management, verification and validation protocols and requirements for electrical, biocompatibility, sterility and human factors
Understanding of ISO 13485, ISO14971, IEC 62366, IEC 623304, IEC 60601
Experience with eQMS/PLM systems, such as Arena
Bold creativity and an indomitable spirit towards problem-solving
Someone who thrives in a fast-paced, energetic environment
Ability to engage a team through excellent written and oral communication
Self-starter who is comfortable with autonomy and operates with a focus on action-biased outcomes
Exceptional level of accountability and integrity
Exemplifies Our Values (see below)
Nice to Haves
Experience in Healthcare or medical device industry
Proficiency in computer skills including G-Suite and Microsoft
Our Values
We are a team of leaders that believe in:
Putting people first, always.
Moving with integrity.
Defining the excellence of tomorrow.
Speaking with purpose and clarity.
Initiative. Accountability. Responsibility. Always. Without exception.
Informed decision making.
No insurmountable obstacles.
Listening as the first step to respectfully offering solutions.
Always learning and embracing change to help our customers provide better healthcare.
