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$144k–$200k/yr
Full-time
bachelor degree, postgraduate degree
Medical Insurance, Dental Insurance, Vision Insurance, Health Savings Account, Flexible Spending Accounts, Employee Life Insurance
Posted 40d ago
~40 hrs/week
Responsibilities
The Director of Operations oversees Quality, Manufacturing Engineering, Production, and Materials Management to achieve best-in-class performance. They are responsible for implementing organizational strategies, driving continuous improvement, and ensuring compliance with ISO and FDA quality systems.
Requirements
A Bachelor's degree in Engineering or Life Sciences is required, along with essential experience in medical device and cleanroom manufacturing. Proficiency in Lean manufacturing and Six Sigma methodologies is necessary for this leadership role.
Full job description
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.
Resolution Medical's Mission is to Provide Innovative Business Solutions to the Medical Device Industry with the Highest Quality and Reliability, Exceptional Customer Service, and with the Resolution to continuously improve life.
Resolution Medical designs, develops, tests, and manufactures medical devices and components in collaboration with its customers.
Offices: 42 Northern Stacks Dr NE, 200, Minneapolis, Minnesota 55421, US · Kennedyplein 10-11, Eindhoven, 5611ZS, NL
ManufacturingResearch & DevelopmentClass 10,000 Clean RoomsLean Manufacturing and Six SigmaPrototypingSterile Kitting & PackagingCathetersCardiac & Neuro LeadsPre-clinical researchQuality & Regulatory