Machine Solutions Engineer
Machine Solutions provides manufacturing and testing equipment for catheter and medical device manufacturers. Vante, as a division of Machine Solutions, is able to provide our customers with a wide range of solutions for medical device manufacturing. Vante provides innovative production equipment for catheter and medical disposables manufacturers. We offer an excellent opportunity for highly motivated individuals in a fast-paced, biotech organization.
General Purpose Of Job: Designs, develops, and tests all aspects of mechanical components, equipment, and machinery within the medical manufacturing industry. Supports customers with tooling orders, including the design, testing, and troubleshooting of mechanical and electromechanical systems. The role involves working closely with product development teams, assisting with the integration of mechanical parts and wiring and air-compressed systems. Collaborating on technical solutions with customers is also part of this job. The individual will handle design revisions, support product planning, and ensure the manufacturability and functionality of equipment for the medical industry.
Essential Duties And Responsibilities:
- Designs, develops, and tests all aspects of mechanical components, equipment, and machinery for medical devices and systems.
- Collaborates with cross-functional teams to integrate mechanical, electrical, and pneumatic components into final designs.
- Evaluates and ensures the design's overall effectiveness, manufacturability, cost, reliability, safety, and compliance with medical industry standards and regulations.
- Provides production supervision of parts and equipment, determines causes of component failures, and tests manufactured products to maintain high-quality standards.
- Supports customers by communicating technical aspects of tooling orders, providing product planning, installation guidance, and operational support.
- Responsible for designing and modifying tooling (molds, dies, etc.) to meet product specifications, in collaboration with product managers or customers.
- Works closely with product managers on product development, assisting with prototype design, testing, and design iterations.
- Utilizes Solidworks® and EPDM® for creating and storing design drawings and documentation, ensuring drawings are compatible with automated manufacturing systems.
- Prepares and revises design documentation, including design variations, engineering change requests (ECNs), and process documentation.
- Leads the development of engineering process documentation, ensuring processes align with regulatory and industry standards.
- Provides support on electromechanical tasks, including reviewing and checking wiring, air-compressed aid tubes, and plumbing diagrams.
- Collaborates with customers on process development and integration, including troubleshooting and offering technical solutions.
- Uses the ERP system (M1) for creating and modifying parts and assemblies for procurement and production.
- May lead or participate in ad-hoc engineering projects, ensuring deadlines and project goals are met.
- Ensures compliance with regulatory standards and participates in audits or reviews.
- Ad-hoc projects as needed.
Supervisory Responsibilities:
- May lead and direct other members of the technical team, including interns and junior engineers, on a project-by-project basis.
- Provides technical guidance and mentorship to less experienced engineers in electromechanical systems and tooling design.
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education And Experience:
- Level 8: Master's degree (M.A.) or equivalent experience in Mechanical or Mechatronics Engineering or related field, plus five to ten years of experience in mechanical design and development within the medical or electromechanical industries.
- Experience with medical device manufacturing, tooling design, and electromechanical systems is highly desirable.
- Experience in process development and supporting customer projects is a plus.
Language Skills:
- Level 5: Ability to read, analyze, and interpret common scientific and technical journals, regulatory documents, and customer specifications. Ability to effectively communicate and present information to customers and management.
Math Skills:
- Level 5: Ability to apply advanced mathematical concepts related to Mechanical Engineering, including statistical analysis, and test reliability. Familiarity with tools like Six Sigma or Design of Experiments (DOE) is a plus.
Reasoning Ability:
- Level 6: Ability to apply principles of logical or scientific thinking to resolve complex engineering problems. Ability to analyze both mechanical and electromechanical systems and their interactions.
Physical Demands:
- Minimal time will be spent standing, walking, stooping, kneeling, and crouching.
- Frequent sitting with hands-on tasks requiring fine motor skills.
- Must be able to lift up to 10 lbs frequently and occasionally up to 50 lbs.
- Ability to adjust focus and maintain close vision for detailed design work.
- Regular use of computer monitor and fine motor skills for precision tasks.
Work Environment:
Minimal time will be spent near fumes or airborne particles, near toxic or caustic chemicals, in outdoor weather conditions, with risk of electrical shock, and with explosives. And some time will be spent working near moving mechanical parts. Moderate noise can be expected.
Barry-Wehmiller is an equal opportunity employer. M/F/D/V This organization uses E-Verify. Applicants may be subject to pre-employment screening which may include drug screening, reference checks, employment verifications, background screening and/or skills assessments.