Senior Sustaining Engineer

Posted 6 Days Ago
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Burnsville, MN, USA
In-Office
100K-145K Annually
Senior level
Biotech • Pharmaceutical
The Role
Ensures the ongoing performance, quality, manufacturability, safety, compliance, and cost-effectiveness of commercialized medical devices and disposable products. Collaborates with manufacturing, R&D, suppliers, customer service, field service, regulatory, and quality teams on obsolescence, root-cause investigations, corrective actions, engineering changes, service fixes, product improvements, technical documentation, audits, and continuous improvement.
Summary Generated by Built In

Description

Supervisor’s Title: VP of Operations
Exempt or Non-Exempt: Exempt

Location: Must be able to work at the Burnsville location

Compensation: The expected salary for this Minnesota-based position is between $100,000 and $145,000. This range represents a good faith estimate for this position. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate’s knowledge, skills, and/or experience. In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental, Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, and Retirement Benefits).

Basic Function 

The Senior Sustaining Engineer works to ensure the continued performance, quality, manufacturability, safety, and compliance of the Company’s commercialized hardware and disposable products. This position is responsible for complying with the Quality System requirements and carrying out responsibilities outlined in the environmental, health, and safety policies. 

Responsibilities 

· Works directly with Customer Service, Field Service Engineers, Manufacturing, and R&D improving product performance, quality, compliance, and cost.

· Develops and implements engineering solutions working collaboratively with Manufacturing, R&D, and Supplier Quality for all part obsolescence activities.

· Supports root-cause investigations and drive timely, effective corrective and preventive actions for field issues, complaints, and nonconformances.

· Develops, evaluates, and implements engineering changes, service fixes, and product updates/improvements/enhancements.

· Coordinates with Regulatory and Quality to prepare technical documentation and support submissions, audits, and investigations.

· Participates in continuous improvement initiatives to reduce field failures, lower cost of service, and improve product quality.

· Other duties as assigned.

Requirements

Qualifications

  • Bachelor of Science in Engineering (Mechanical, Electrical, Biomedical, or      related).
  • 5-7 years’ experience in medical device manufacturing. 
  • Must enjoy hands-on product exposure.
  • Ability to interpret engineering drawings and schematics.
  • Multi-tasking, problem solving and strong communication skills a must.

Working Conditions

· Light work, exerting up to 40 lbs. of force or less.

· 85% of the time requires viewing and working on a computer screen.

· Significant work pace & pressure due to deadlines.

· Travel 5%

The statements above reflect the principal function and most significant duties of the job as necessary for its evaluation in relation to other jobs in the organization and shall not be construed as a detailed description of all the work requirements that may be inherent in the job. Any functions that are non-Essential will be identified as such above. A request for Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.

Skills Required

  • Bachelor of Science degree in Engineering, such as Mechanical, Electrical, Biomedical, or a related field
  • 5–7 years of experience in medical device manufacturing
  • Hands-on product exposure
  • Ability to interpret engineering drawings and schematics
  • Multitasking, problem-solving, and strong communication skills
  • Ability to work at the Burnsville, Minnesota location
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The Company
Burnsville, MN
63 Employees

What We Do

Imricor Medical Systems develops magnetic resonance imaging compatible electrophysiology tools for the treatment of cardiac arrhythmias.

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