Director of Operations

Posted 3 Days Ago
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Fridley, MN, USA
In-Office
144K-200K Annually
Senior level
Healthtech • Professional Services • Design • Manufacturing
The Role
Lead all operations including quality, manufacturing engineering, production, and materials. Set strategy, drive continuous improvement (Lean/Six Sigma), ensure ISO/FDA compliance, manage budgets/forecasts, monitor performance metrics, and develop talent to meet revenue, cost, and quality targets in a medical device cleanroom environment.
Summary Generated by Built In

Description

Company Overview

Resonetics is a global leader in advanced engineering, prototyping, product development, and micro manufacturing, driving innovation in the medical device industry. With rapid expansion across all our locations, we continue to push the boundaries of technology while fostering a dynamic, employee-centered culture. Our commitment to excellence and continuous improvement makes Resonetics an exciting place for professionals passionate about shaping the future of micro-manufacturing and being part of something bigger. This role supports the Resolution Medical team, a newly acquired business who is the nation’s largest full medical device development company with full manufacturing services based in Fridley, MN.

Job Description 

The Director, Operations has overall responsibility for all areas of operation including Quality & Manufacturing Engineering, Production & Materials Management. The person in this position leads the development and implementation of organizational strategies, standards and practices to achieve best-in-class performance. In addition, the Director, Operations collaborates closely with other leadership across the business to leverage resources and expertise to ensure our products are consistently meeting customer expectations.  

Essential Functions:

  • Lead with a clear view of where the organization needs to be in 1-3 years; communicates strategic direction to employees and how it fits with the day-to-day actions and results being driven.
  • Identify and drive continuous improvement efforts through standardized work to cut cost and improve productivity and quality.
  • Set clear and measurable performance expectations, in line with corporate goals; proactively analyze and manage all relative operations performance metrics.
  • Provide timely, accurate and complete reports on the operating conditions of the company.
  • Establish and monitor quality objectives.
  • Ensures alignment with functional leadership (e.g., finance, safety, human resources) on performance management and talent development.
  • Ensure the facilities operate within the Company’s ISO and FDA quality management system.
  • Participate in the development of the location’s monthly revenue forecasts.
  • Monitor and adjust production output and staff levels to support the location’s revenue and cost targets.
  • Participate in the development and control of the location’s budgets and quarterly forecasts.
  • Working with the senior leadership team, help to develop and implement winning strategies to grow revenues and profitability.

Requirements

  • Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
  • Proven experience leading a manufacturing department or organization in a technical manufacturing environment.
  • Medical device manufacturing experience is essential.
  • Experience working in a cleanroom manufacturing environment is essential.
  • Experience with Lean manufacturing principles and Six Sigma methodologies, including continuous improvement initiatives.

Preferred Qualifications

  • Prior experience managing an independent manufacturing organization.
  • Familiarity with contract manufacturing, ISO and FDA quality system requirements, medical device and diagnostics manufacturing.
  • Lean, six-sigma green or black belt certified.
  • Packaging and distribution of finished medical devices.
  • MBA or relevant business management experience 

Physical Requirements

  • Ability to work long hours when necessary and to have a presence with a 24/7 operation.
  • Ability to travel up to 10% as business needs dictate. 

Summary of Benefits

  • Group health & welfare benefits: Options for Medical, Dental and Vision insurance, Health Savings Account (requires participation in eligible medical plan), and Flexible Spending Accounts.
  • Company-paid benefits: Employee Life Insurance & Accidental Death & Dismemberment (AD&D), Long Term Disability (LTD), Kavira (requires participation in medical plan).
  • Voluntary, employee-paid benefits: Employee Supplemental Life & AD&D, Spouse and Dependent Life & AD&D, Short Term Disability (STD), Accident, Critical Illness, and Hospital Indemnity, Employee Assistance Program.
  • Flexible Time Off Program
  • Paid Parental Leave
  • Paid Holidays 
  • Benefits and incentive compensation may be subject to generally applicable eligibility, waiting period, contribution, and other requirements and conditions.

 Compensation

  • The typical base pay range for this role is between $144,000-$200,000/year. Actual base compensation will be based on individual job-related knowledge, skills, expertise, and experience. 
  • This position is eligible for a discretionary annual incentive program driven by organization and individual performance.
  • 401(k) Plan: Company-provided Safe Harbor Contribution of 3% of eligible earnings.

Skills Required

  • Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
  • Proven experience leading a manufacturing department or organization in a technical manufacturing environment.
  • Medical device manufacturing experience.
  • Experience working in a cleanroom manufacturing environment.
  • Experience with Lean manufacturing principles and Six Sigma methodologies, including continuous improvement initiatives.
  • Ability to work long hours and support a 24/7 operation.
  • Ability to travel up to 10% as business needs dictate.
  • Prior experience managing an independent manufacturing organization.
  • Familiarity with contract manufacturing, ISO and FDA quality system requirements, medical device and diagnostics manufacturing.
  • Lean Six Sigma green or black belt certification.
  • Packaging and distribution of finished medical devices experience.
  • MBA or relevant business management experience.
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The Company
Year Founded: 2012

What We Do

Resolution Medical, LLC is a medical device development and manufacturing company specializing in complex delivery systems, active implantable devices, and component manufacturing. They provide comprehensive support from concept development through commercial-scale manufacturing for Class I, II, & III medical devices.

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