Senior Manufacturing Engineer

Hours:

Monday to Thursday – 4:45am to 3:15pm

Description:

This position works out of our Minnetonka MN location in Client Electrophysiology (EP) business.

Individuals in this role will work on a new product launch supporting the operations team as a Manufacturing Engineer working with assemblers, and leading technicians on troubleshooting equipment and investigating process issues. Additionally, this position will support projects aimed towards designing and developing manufacturing processes, tooling, and fixtures to meet daily production schedules while enhancing productivity and product quality. This individual will have a unique opportunity to make a mark on the organization, while working on state-of-the-art product.

• Front line Manufacturing Engineer supporting Operations team in a clean room environment.
• Support products which include new production equipment, process improvements and cost reductions while supporting new product introductions.
• Lean manufacturing processes, techniques and best practices and support Operations team in coaching assemblers through daily activities and training certifications.
• Instruct production personnel in the manufacturing and testing of product devices.
• Recommend and implement process, tooling, equipment changes for improving safety, quality, delivery and cost.
• Interpret test data, analyze product performance, develop summaries, and assist in the initiation of yield improvements.
• Daily troubleshooting of safety, quality, or process issues.
• Perform scrap dissection and lead investigation into potential root causes.
• Summarize information to communicate across shifts and with other functional areas, and reporting to leadership team.

• Be innovative, resourceful, and work with minimal direction.
• Have excellent organization, problem solving, communication, and collaboration skills.
• Work effectively with cross-functional teams.
• Exercise technical knowledge to support achievement of business objectives through launch of the product, volume ramp and yield improvement, which will require setting direction, leading, and taking ownership of complex manufacturing engineering technical tasks with multiple inter-coordinating elements.
• Anticipate and identify key issues, understand impact and make recommendations for resolution which remain compliant with Quality System requirements.
• Obtain peer review and manager review to confirm rationale for the approach is appropriate.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

• The individual will have 5+ years of experience in an engineering discipline or advanced education to achieve the level of skill.
• Bachelor Science or Bachelor Engineering in Electrical, Mechanical or Biomedical Engineering or similar is desired.
• Curriculum training will be provided to ensure understanding of Quality System requirements required to perform assignments.
• This position is Nonexempt. Hours over 40 will be paid at Time and a Half.

• Minimum 5 years’ experience required: prior relevant manufacturing or technician background.
• Ability to operate manufacturing equipment.
• Manufacturing process understanding and support.
• Root cause analysis/problem solving.
• Preference for candidates from the medical device industry (Class II or Class III), though automotive testing experience is also acceptable.
• Previous experience in lean manufacturing.
• Need to be able to work and communicate clearly with many different groups.
• Floor support experience preferred but not required. Position will be primarily supporting the floor with some small equipment validation.

• The role involves hands‑on floor support, not purely design or validation.
• Could include a blend of support tasks depending on workflow needs.
• Functional collaboration is important for decisions, compliance adherence, and solution evaluation.

• Potential for extension or conversion to full-time depending on business need and worker performance.