Senior Systems Engineer

Ximedica is an ISO 13485 certified and FDA registered full-service product development firm with offices in Providence, Minnesota, San Francisco, Los Gatos, and Hong Kong. We have an exclusive focus on medical products and over 25 years of experience developing medical devices, combination products and consumer healthcare products. We have a high-energy collaborative culture that fosters the creative spirit while exceeding client expectations. We offer tremendous opportunity for professional development and leadership, rewarding projects, competitive salaries, an excellent benefits package, and summer hours.

The Product Development Engineer supports our domestic and international product development business.

Nature of Role: Reporting to the Head of Systems Engineering, the Product Development Engineer is responsible for various systems engineering functions within multiple projects.

The main objectives are to ensure proper translation of user, caregiver and a variety of additional stakeholders’ needs into clearly defined, verifiable design inputs. Collaborate with project teams to define system solutions, architectures (design outputs) and interface requirements between various subsystems to adequately meet the design inputs.

Additional activities include determining the essential requirements necessary to drive initial concept development, leading systems architecture concept development sessions, and creating ratings criteria for concept ranking, prioritizing the development strategy and acceptance of early architectural concepts. Act as the hub of the product development team by engaging all engineering disciplines (including but not limited to Mechanical Engineering, Electrical Engineering, and Software Engineering architects) to organize system architectures and product development activities. Parallel activities will include translating the early research findings and regulatory requirements into functional requirements with documented rationales, intended to be measurable and verifiable or validated at later stages. Late stage activities include advising on formal verification plans in collaboration with Design Assurance Engineers for risk assessments and assisting with test method development. The role will also require incorporation of directly related standards and regulatory requirements.

Responsibilities:

  • Lead systems engineering efforts and drive related deliverables on multiple project
  • Develop design input requirements, exercise analysis tools such as parsing, and ensure rationales are provided for requirements
  • Ensure compliance to appropriate regulatory standards for the product
  • Collaborate with user research specialists to gather and prioritize stakeholder needs
  • Work with clients to gather and prioritize business needs and pre-defined design constraints
  • Define essential requirements necessary to drive very early concept development
  • Lead systems architecture concept development sessions; create rating criteria for concept ranking and acceptance of early architectural concepts
  • Translate early research findings and regulatory requirements into functional requirements.
  • Capture the evolution and ultimate systems design output, rationales, and lower level requirements associated with final design
  • Contribute to formal verification planning in collaboration with assigned Design Assurance Engineers, and assist with test method identification and development
  • Keep abreast of related laws and regulations, and incorporate compliance within systems engineering deliverables
  • Participate in continuous improvement efforts related to systems engineering processes
  • Assist the Head of Systems Engineering with staff training on a periodic basis and teams on an as needed basis

Requirements:
An individual holding a bachelor’s degree in a related field, coupled with minimum of 8 years of experience within the product development industry. Familiarity with related standards and medical device development is a plus. Experience with typical industry requirement management systems is a plus. Our fast-paced environment demands the ability to manage multiple projects within the discipline and deadlines. High-energy, self-starters with the following qualities:

  • Successful communication skills, business acumen and assertive decision-making ability
  • Flexibility to multi-task and perform a wide range of activities
  • Excellent computer skills, including MS Office proficiency

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