Design Engineer II
The ideal candidate will be responsible for executing and leading the full design process from ideation to production and updating our current designs. Will have a strong background in the design of medical devices, medical assemblies, surgical tools, and/or robotics used in medical applications. Needs to have a strong understanding of electrical requirements for medical products and how that translates into the design aspect with the cabling components which supply power, control, and signal to the device. Should have direct experience working in an ISO 13485 environment and in their current role be utilizing SolidWorks or CAD on a constant basis to create drawings. They also need to have a very strong background in creating DFMEAs and owning projects directly as an individual contributor who is part of a larger technical team.
This position will take direction from the Director of R&D and work with sales (inside & outside), field application engineers and customers to obtain necessary customer requirements and translate requirements into design solutions. This position will work with internal personnel to release products to the production environment. Design Engineers will work closely with Document Control and Process Engineers to support seamless integration of new products and/or engineering changes.
- Own documentation management and design activity for new and existing product.
- Review designs and ensure compliance with all necessary performance specifications.
- Translate RFQs and internal development needs into application specific product designs.
- Input cable architecture, assembly, and customer requirements into internal cable building software.
- Maintain accurate design layouts in cable building software through engineering change orders.
- Manage new material requests for incoming and existing designs in QCBD.
- Integration of new part numbers to the organization.
- Technical design lead for risk and feasibility evaluation.
- Responsible for DFMEA, DVVP&R, and Critical Design Review.
- Interface with customers, sales, and FAEs to obtain or clarify product information for drawing approvals.
- Bachelor’s degree in Engineering and 5 to 10 years’ experience in a product design, or equivalent education and experience.
- Extensive experience with SolidWorks or CAD programming to create 3D product models.
- Design experience with extrusion processes utilizing PVC, Polyolefins, TPE, Nylon, Polyurethane, Fluoropolymers, and Cross-Linked Polyethylene for copper conductor insulation and jackets.
- Knowledge of regulatory requirements and their impact on design (UL, CSA, ISO, FDA, etc.).
- Ability to pick up new technologies quickly and demonstrate proficiency in understanding requirements.
- Direct communication style to support cross-functional involvement.
- Ability to make independent decisions.
Northwire, Inc. is an Equal Opportunity Employer – M/F/D/V