Systems Hardware Design Engineer

Overview
The Systems Hardware Design Engineer conceptualizes, designs, assembles and tests new and innovative products as a primary team member on the R&D project team. Responsible for organizing highly complex activities for the design, development, implementation, and maintenance of engineering projects. The position also requires the team member to have operational working knowledge and know-how in design controls, risk management, human factor engineering, compliance to medical device safety standards, as well as participation in preclinical & clinical development including regulatory support.

Duties and Responsibilities

Lead project in designing and integrating human interface devices (capital equipment) with a focus on user experience, clinical usability and compliance.
Machine, build, assemble and test performance of engineering prototypes, iterations, and subsequently DVT & clinical builds to support clinical trials or commercialization; wherever relevant, machine, build, assemble and verify performance of test fixtures to support manufacturing builds.
Document all R&D activities and results in Company’s issued notebook. Wherever relevant, initiate or write standard operating procedures, process instructions, assembly instructions, specifications, etc., to ensure project activities are properly recorded.
Develop, evaluate, and improve manufacturing methods; support transitioning investigational device through product development to manufacturing/production; support manufacturing and process optimization.
Adhere to Clients Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing.
Contribute to Company’s intellectual properties by participating in writing and reviewing of invention disclosures and patent applications.
Interface with vendors to discuss and collaborate on design.
Perform other work-related duties as assigned.

Requirements

Bachelor’s degree in Industrial Engineering, Bio-/Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Electromechanical Engineering or Aerospace Engineering.
Minimum of 5 years in Medtech with prior experience in bringing a medical device from the design stage to commercialization.
Experience with hands-on mechanical engineering design skills with Solidworks.
Experience with electronics design, PCB layout and fabrication.
Excellent working knowledge in IEC60601, IEC62366 and ISO14971 compliance.
Working knowledge with IEC60825 a plus.
Prior experience in cardiovascular interventions and hands-on experience a plus.
Advanced problem-solving, organizational, analytical and critical thinking skills, with strict attention to detail.
Ability to work on unusually complex technical problems and provide solutions which are highly innovative and creative, compare and evaluate possible courses of action after considering various possibilities, and make decisions in the face of different alternatives and without formulas or guidelines, or with guidelines that are not complete and exhaustive.
Ability to develop expertise or recognized as an expert in a technical area, and maintain technical know-how, looking ahead to identify technical gaps and taking action to address them.
Ability to work independently and meet development schedule without close supervision; work is generally self-guided with adherence to established patterns and practices.
Ability to communicate or articulate to the team complex issues and mitigations after considering potential risks of alternatives; excellent documentation and communication skills and interpersonal relationship skills including negotiation and relationship management skills.
Ability to interact professionally at all organizational levels.
Ability to manage competing priorities in a fast-paced environment.
Acceptance to be overseen by managers and more senior team members.
Ability and willingness to supervise others in resolving complex issues in specialized area based on existing solutions and procedures.
Ability to provide guidance for the successful completion of major programs and may function in a project leadership role.