Sr. Manufacturing Engineer
Overview
At Spacelabs Healthcare, we are on a mission to provide continuous innovation in healthcare technology for better clinical and economic outcomes. Our scalable solutions deliver critical patient data across local and remote systems, enable better-informed decisions, increase efficiencies, and create a safer environment for patients.
Why work at Spacelabs? Because lives depend on you!
This position is responsible for engineering support of the assigned product portfolio. It is part of a multi-disciplinary team and a high level of collaboration with other members is essential to the overall success of the team.
Primary focus is New Product Introduction and sustaining engineering; New Product Introduction responsibility includes collaboration with the R&D team to ensure new products are manufacturable, testable, serviceable and reliable; line design and process development in line with established lean principles; quality metrics tracking during early production phases; transitioning new product knowledge into sustaining engineering team. Sustaining engineering responsibility includes sustaining existing product portfolio; responsibilities include quality improvements, customer responsiveness improvements, cost reduction, alternative component selection and approval.
Responsibilities
Develop, document and improve manufacturing processes. Create process plans and equipment designs, and document process validations. Perform product and process verifications and validations.
Configure, download and test configurations of products at company and contract manufacturers.
Make product design improvements, including cost reductions and reliability improvements, as part of a team or as team lead for product improvement projects.
Maintain bills of materials, drawings, specifications, licenses and their associated changes.
Work with the materials support team to certify vendors for direct to stock/line programs. Resolve vendor quality issues, disposition/reduction of discrepant materials.
Provide knowledge and assistance to the new product development (R&D) process, production and materials teams.
Complete root cause failure analysis and corrective actions for field failures, production problems and failed components; and create engineering changes including validation testing. This includes approval of documents and training affected personnel.
Able to work with external resources, can be a team lead representing Operations/Mfg Engineering on cross functional teams.
Maintain the integrity and quality of our products, ensuring conformance to specifications and compliance with all regulatory requirements, including FDA, MDD, UL, CSA, etc.
Ensure that safe operating procedures are developed, communicated, and followed by all personnel.
Uphold the Company's core values of Customer Obsession, Ownership Mindset and Superior Results.
Demonstrate behavior consistent with the Company's Code of Ethics and Conduct.
It is the responsibility of every Spacelabs Healthcare employee to report to their manager or a member of senior management any quality problems or defects in order for corrective action to be implemented and to avoid recurrence of the problem.
Duties may be modified or assigned at any time to meet the needs of the business.
Qualifications
BS degree in Electrical Engineering, Manufacturing Engineering or other related technical field, (4 years of directly related experience may be substituted for the educational requirement).
8
years of related experience in manufacturing environment; experience in medical device or capital equipment preferred. Experience working in an FDA-controlled environment is highly desirable. (Overall experience determines level).
May require specific experience in one or more of the engineering disciplines (electrical, manufacturing, system test, etc.), based on the needs of the business.
Ability to manage multiple, complex priorities within demanding timeframes. Project management and problem-solving skills.
Some travel may be required; for international travel must be able to acquire all necessary travel documents
. Apply now!Estimated Salary: $20 to $28 per hour based on qualifications.
At Spacelabs Healthcare, we are on a mission to provide continuous innovation in healthcare technology for better clinical and economic outcomes. Our scalable solutions deliver critical patient data across local and remote systems, enable better-informed decisions, increase efficiencies, and create a safer environment for patients.
Why work at Spacelabs? Because lives depend on you!
This position is responsible for engineering support of the assigned product portfolio. It is part of a multi-disciplinary team and a high level of collaboration with other members is essential to the overall success of the team.
Primary focus is New Product Introduction and sustaining engineering; New Product Introduction responsibility includes collaboration with the R&D team to ensure new products are manufacturable, testable, serviceable and reliable; line design and process development in line with established lean principles; quality metrics tracking during early production phases; transitioning new product knowledge into sustaining engineering team. Sustaining engineering responsibility includes sustaining existing product portfolio; responsibilities include quality improvements, customer responsiveness improvements, cost reduction, alternative component selection and approval.
Responsibilities
Develop, document and improve manufacturing processes. Create process plans and equipment designs, and document process validations. Perform product and process verifications and validations.
Configure, download and test configurations of products at company and contract manufacturers.
Make product design improvements, including cost reductions and reliability improvements, as part of a team or as team lead for product improvement projects.
Maintain bills of materials, drawings, specifications, licenses and their associated changes.
Work with the materials support team to certify vendors for direct to stock/line programs. Resolve vendor quality issues, disposition/reduction of discrepant materials.
Provide knowledge and assistance to the new product development (R&D) process, production and materials teams.
Complete root cause failure analysis and corrective actions for field failures, production problems and failed components; and create engineering changes including validation testing. This includes approval of documents and training affected personnel.
Able to work with external resources, can be a team lead representing Operations/Mfg Engineering on cross functional teams.
Maintain the integrity and quality of our products, ensuring conformance to specifications and compliance with all regulatory requirements, including FDA, MDD, UL, CSA, etc.
Ensure that safe operating procedures are developed, communicated, and followed by all personnel.
Uphold the Company's core values of Customer Obsession, Ownership Mindset and Superior Results.
Demonstrate behavior consistent with the Company's Code of Ethics and Conduct.
It is the responsibility of every Spacelabs Healthcare employee to report to their manager or a member of senior management any quality problems or defects in order for corrective action to be implemented and to avoid recurrence of the problem.
Duties may be modified or assigned at any time to meet the needs of the business.
Qualifications
BS degree in Electrical Engineering, Manufacturing Engineering or other related technical field, (4 years of directly related experience may be substituted for the educational requirement).
8
years of related experience in manufacturing environment; experience in medical device or capital equipment preferred. Experience working in an FDA-controlled environment is highly desirable. (Overall experience determines level).
May require specific experience in one or more of the engineering disciplines (electrical, manufacturing, system test, etc.), based on the needs of the business.
Ability to manage multiple, complex priorities within demanding timeframes. Project management and problem-solving skills.
Some travel may be required; for international travel must be able to acquire all necessary travel documents
. Apply now!Estimated Salary: $20 to $28 per hour based on qualifications.
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