Job Description:
As a key member of our team, you will lead product development activities for customer projects from conception to delivery.
Key Responsibilities:
* Define and resolve customer requirements into solutions and translate them into product specifications for transfer to production.
* Develop user-focused product solutions optimized for manufacture through engineering expertise.
* Design and develop mechanical solutions for early-stage and end-stage product development.
* Perform risk assessment and management in line with ISO 14971 standards.
* Conduct prototyping and testing of concept designs and initial engineering builds.
* Utilize CAD skills in SolidWorks to create complex assemblies, surface modeling, and 2D drawings.
* Pilot production trials to assess concept feasibility and troubleshoot design risks.
* Develop product specifications and test methods, documenting them in product input/output format.
* Analyze product test data statistically using Minitab or equivalent software.
* Perform design verification, including the development of test protocols and conducting testing as per ISO 13485/customer requirements.
* Collaborate with the design team to define and complete product validation and usability testing.
* Work with customers to complete design and technical reviews.
* Coordinate with process development and production teams to complete transfer to production and pre-production planning.
* Exercise strong initiative and follow-through in executing project responsibilities, overcoming obstacles, and balancing multiple priorities effectively.
Requirements:
* Strong technical leadership experience and project management skills.
* Excellent problem-solving and analytical abilities.
* Proficiency in CAD tools, particularly SolidWorks.
* ISO 14971 and ISO 13485 knowledge.
* Statistical analysis skills using Minitab or equivalent software.
* Effective communication and collaboration skills.
Benefits:
We offer a dynamic work environment, opportunities for professional growth, and competitive compensation.