Hardware Integrator - Healthcare
Apply NowCompany: Quest Global Manufacturing
Location: Waukesha, WI 53188
Description:
Job Requirements
Engineering Change Management:
Oversee ECR (Engineering Change Request), ECO (Engineering Change Order), and MR (Manufacturing Release) processes to implement engineering changes effectively. o Ensure all change management activities comply with regulatory and organizational standards.
2. NPI Program Support: o Drive New Product Introduction (NPI) initiatives by completing assigned tasks to meet program goals. o Collaborate with cross-functional teams to streamline NPI-related processes.
. Integration & Collaboration:
Support Lead Hardware Integration (LHI) and Hardware Integration (HI) activities across departments. o Serve as a technical liaison between engineering, manufacturing, and quality assurance teams.
4. Design Understanding: o Leverage advanced knowledge of mechanical or electrical-electronics design and drawings to aid integration and problem-solving tasks. o Utilize tools like CREO and Windchill to support design and documentation needs.
Compliance & Regulations:
Ensure adherence to compliance requirements, including FDA and NMPA regulations.
Address legacy system constraints to improve integration and compliance.
6. Problem Solving & Timely Delivery:
Deliver projects and tasks on schedule, resolving technical and operational challenges independently.
Work Experience
Experience:
o Proven expertise in change management processes (ECR/ECO/MR).
o Demonstrated work in mechanical or electrical-electronics engineering roles, preferably in the healthcare sector.
Technical Skills:
o Expertise in engineering life cycle tool.
o Strong ability to read and interpret design drawings.
o Proficiency in CREO and Windchill is a plus.
o Leadership experience is a plus.
Compliance Knowledge:
o Familiarity with FDA and NMPA regulations.
o Understanding of compliance standards and legacy system constraints
Engineering Change Management:
Oversee ECR (Engineering Change Request), ECO (Engineering Change Order), and MR (Manufacturing Release) processes to implement engineering changes effectively. o Ensure all change management activities comply with regulatory and organizational standards.
2. NPI Program Support: o Drive New Product Introduction (NPI) initiatives by completing assigned tasks to meet program goals. o Collaborate with cross-functional teams to streamline NPI-related processes.
. Integration & Collaboration:
Support Lead Hardware Integration (LHI) and Hardware Integration (HI) activities across departments. o Serve as a technical liaison between engineering, manufacturing, and quality assurance teams.
4. Design Understanding: o Leverage advanced knowledge of mechanical or electrical-electronics design and drawings to aid integration and problem-solving tasks. o Utilize tools like CREO and Windchill to support design and documentation needs.
Compliance & Regulations:
Ensure adherence to compliance requirements, including FDA and NMPA regulations.
Address legacy system constraints to improve integration and compliance.
6. Problem Solving & Timely Delivery:
Deliver projects and tasks on schedule, resolving technical and operational challenges independently.
Work Experience
Experience:
o Proven expertise in change management processes (ECR/ECO/MR).
o Demonstrated work in mechanical or electrical-electronics engineering roles, preferably in the healthcare sector.
Technical Skills:
o Expertise in engineering life cycle tool.
o Strong ability to read and interpret design drawings.
o Proficiency in CREO and Windchill is a plus.
o Leadership experience is a plus.
Compliance Knowledge:
o Familiarity with FDA and NMPA regulations.
o Understanding of compliance standards and legacy system constraints