About the Role
We are seeking an experienced systems engineer to join our team. In this role, you will contribute technically and provide leadership in developing medical device product systems from initial concept through to product launch.
Key Responsibilities
* Support acquisition and integration activities for complex active implantable product systems.
* Provide due diligence support through technology evaluations, gap assessments and remediation planning including partnership with cross-functional teams.
* Support systems requirements and design modifications needed for seamless integration of product systems.
* Translate user needs into design requirements consisting of system requirements, sub-system requirements, product/system security requirements, and system interface requirements.
* Support system architecture, design and integration of new or next generation technologies/products (implantable & capital platform eco-systems) under quality system in collaboration with technical/cross-functional stakeholders.
* Identify technical risks, develop risk burndown plans, and implement phased system integration approaches, characterization studies to mitigate risk.
* Analyze system requirements to determine testability, completeness and support system test development, systems characterization, test method development and build traceability.
* Contribute to system risk assessment activities, Use/Design FMEA's activities.
* Support product/feature design, concept generation and functional prototyping for systems and associated interfaces.
* Act as a representative on cross-functional deliverables.
* 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.
* Collaborate with R&D, regulatory, quality, project management teams for integration activities and communicate findings/recommendations to senior leadership and key stakeholders.
* Champion functional best practices and problem solving across functions/divisions and disciplines via internal/external experts to resolve difficult challenges.
* Mentor 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.
Requirements
* Bachelor’s degree in Engineering or related field.
* Minimum 5 years of experience in systems engineering with strong technical background.
* Experience in medical device industry or similar fields.
* Strong analytical and problem-solving skills.
* Ability to lead cross-functional teams.
* Excellent communication and interpersonal skills.
* Proficient in Agile/Lean methodologies.