What you will do-
The expectation of the role is to perform validation and verification of product and process changes to the Autoplex line and re-processed products, follow up on containment activities due to CAPAs and NCRs. Actualization of BOMs and routings in SAP. All this adheres to regulatory requirements, project deadlines and product costs targets. This will be the only role in STJ with experience in electronics and the first one ever.
Technical Responsibilities:
• Independently design and develop electrical components and sub-systems for medical devices. Develop and apply advanced circuit and electrical system test methods. Conduct advanced prototyping and testing.
• Conduct advanced problem solving, identify potential solutions, and evaluate them against component and sub-system requirements. Conduct and design research and studies to support advanced product design. Translate user’s need to design inputs/specifications and produce advanced component and sub-system level designs.
• Analyze and correct complex product design issues, using independent judgment. Independently balance design tradeoffs while designing a component of the system.
Business Responsibilities:
• Advance solutions by applying in-depth knowledge of customer needs, market and competitive offerings. Apply detailed knowledge of clinical procedures to author design input. Support Voice of Customer sessions internally and with clinicians. Demonstrate developing financial acumen.
Medical Device Compliance:
• Be proficient with and mentor others in the usage of industry standards, including design requirements and test strategies per applicable regulations. Lead creation and refinement of engineering documentation, such as the Design History file. Follow and mentor others on R&D procedures like design controls and risk management, per the Quality Management System.
General Responsibilities:
• Work cooperatively with R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing and Project Management to ensure project success as a leader on the team. Identify and support the creation of or improvements to procedures, policies, processes, systems, and technology.
•Support and execute segments of complex product development to advance projects through the design /development/launch process.
• Contribute to product development from concept through release. Deliver high quality results with passion, energy and drive to meet business priorities. Build relationships and influence the engineering groups within the business.
What you need-
Minimum Qualifications (Required):
• Bachelor’s degree in Engineering.
• 3+ years of work experience.
• Advanced understanding of electrical components and manufacturing methods including common failure modes.
• Ability to interpret, analyze, and test electrical designs.
• Working knowledge of the electrical design process.
• Proficiency in the use of CAD and/or other circuit design and analysis tools to design.