Medical Device Project Lead Lean & Regulatory
Dormont Manufacturing Company
Freudenberg Medical LLC in Minnesota seeks an engineering professional to lead cost modeling, make-vs-buy decisions, and guide Lean/Six Sigma initiatives in medical device manufacturing. You will ensure design history files, device master records, and validation activities meet regulatory requirements, mentor team members, and deliver on scope, schedule, and budget. Bachelor’s degree required; 3+ years in medical devices; ISO/GMP knowledge. #J-18808-Ljbffr Dormont Manufacturing Company
- ...global technology group is looking for a Project Manager to lead the development of cost models, track... ...over 3 years of experience in the Medical Device industry and 2 years in a leadership... ...knowledgeable about ISO standards and Lean/Six Sigma methodologies. This...RegulatoryMedical deviceFull time
$85k - $115k
A leading medical device manufacturer is looking for a skilled Project Manager in Minnetonka. You will lead projects focused on manufacturing cost models, track performance metrics, and ensure compliance with ISO standards. The ideal candidate has a degree in a relevant...RegulatoryMedical device$78k - $156k
...the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded... ...countries. JOB DESCRIPTION: NPI Project Sourcing Lead Working at Abbott... ...Administration (FDA) regulations, other regulatory requirements, Company policies,...RegulatoryMedical deviceLong term contractFull timeFor contractorsLocal areaWorldwideShift work$39 - $42 per hour
...Work in collaboration with Team Leads to achieve production plans.... ...environment, i.e. medical devices or other industries governed... ...Federal, State and Corporate regulatory policies. Experienced with root cause problem solving and lean manufacturing tools/practices...RegulatoryMedical deviceHourly payWork at office- ...Medical Device Assembler Medical Device Assembler Shift Timings: Mon-... ...cardioverter defibrillators (ICDs), leads, and related assemblies. The... ...Management Systems (QMS) and regulatory requirements. Maintain... ...in continuous improvement and Lean Manufacturing initiatives to...RegulatoryMedical devicePermanent employmentShift work
- ...Responsibilities: Lead development of accuratemanufacturing... ...for development, project progression, and... ...‑improvement and Lean/Six Sigma... ..., innovation, and regulatory excellence across... ...history files, device master records,... ...years’ experience in Medical Device or related...RegulatoryMedical deviceWork at office
- ...Entry-level assembly aptitude (medical device experience a plus). Good hand... ...defibrillators (ICDs), leads, and related medical device assemblies... ...a basic understanding of Lean Manufacturing. Participate... ...Management Systems (EMS), and other regulatory requirements. Ability to read...RegulatoryMedical deviceContract work
- ...position will support projects aimed towards designing... ...introductions • Lean manufacturing processes... ...and testing of product devices • Recommend and implement... ...(EMS), and other regulatory requirements. •... ...Qualifications: • Medical device experience preferred...RegulatoryMedical deviceFor contractorsShift work
$18.75 per hour
...Responsibilities Assemble, repair, and test medical devices according to standardized procedures... ...Quality Management Systems (QMS) and regulatory requirements. Maintain accurate... ...Participate in continuous improvement and Lean Manufacturing initiatives to improve...RegulatoryMedical deviceHourly payShift work$220k - $225k
...Trelleborg Medical Solutions is seeking a VP... ...Global Quality and Regulatory, based from their... ...autonomy and support to lead the production... ...of life-saving devices. Growth and advancement... ...Deploys Lean/Six Sigma or equivalent... ...for assigned projects including 510(k) and...RegulatoryMedical deviceFixed term contract- ...the production of high-quality medical devices within a manufacturing cell.... ...defibrillators (ICDs), leads, and related assemblies. The... ...Demonstrate a basic understanding of Lean Manufacturing principles.... ...Management Systems (EMS), and regulatory requirements. Required skills...RegulatoryMedical deviceAfternoon shift
$17 - $18.75 per hour
...the production of high-quality medical devices within a manufacturing cell.... ...defibrillators (ICDs), leads, and related medical device assemblies... ...a basic understanding of Lean Manufacturing. Participate... ...Management Systems (EMS), and other regulatory requirements Ability to read,...RegulatoryMedical deviceHourly payContract workRemote workShift work- Hims & Hers is looking for a VP, Regulated Device Engineering to lead the medical device business. This role involves overseeing R&D, ensuring compliance... ..., and a proven track record in product development and regulatory processes. Hims & Hers offers a competitive salary,...RegulatoryMedical device
$14.35 - $28.75 per hour
...the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded... ...Demonstrates a basic understanding of Lean Manufacturing.... ...Management Systems (EMS), and other regulatory requirements Shift...RegulatoryMedical deviceHourly payShift work$88.25k - $117.5k
...engineering duties and project assignments based on... ...guidance from supervisor or lead engineers. Use... ...design solutions for medical devices. Use 2D and 3D cad... ...Service, Supply Chain, Regulatory Affairs, Vendors, Suppliers... ...Experience with Lean Six Sigma / (DFMA) Design...RegulatoryMedical deviceTemporary workFor contractorsLocal area$61.3k - $122.7k
...the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded... ...methodologies (e.g., Six Sigma and Lean Manufacturing) Lead the investigation... ...Systems (EMS), and other regulatory requirements. Complies with...RegulatoryMedical deviceWork experience placementShift work- ...company merger, we are hiring over 10 Medical Device Assemblers with cleanroom experience.... ...and procedures to ensure compliance with regulatory requirements. Contribute to process... ...device manufacturing. Familiarity with Lean Manufacturing principles and continuous...RegulatoryMedical deviceTemporary workLocal areaMonday to Friday
$14.35 - $28.75 per hour
...the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded... ...Demonstrates a basic understanding of Lean Manufacturing. Demonstrates... ...Systems (EMS), and other regulatory requirements Required Qualifications...RegulatoryMedical deviceHourly payShift workAfternoon shift- ...the production of high-quality medical devices within a manufacturing cell.... ...defibrillators (ICDs), leads, and related medical device assemblies... ...a basic understanding of Lean Manufacturing. Participate... ...Management Systems (EMS), and other regulatory requirements. Ability to read...RegulatoryMedical device
$100.9k - $151.3k
...Control Manager Cretex Medical is a leading contract manufacturer... ...for the medical device industry. Our customers... ...control strategies, regulatory compliance, and... ...Requirements: Lean/Six Sigma experience... ...help you figure out a project and get it done right...RegulatoryMedical deviceHourly payContract workTemporary workLocal areaShift work$70.2k - $105.32k
Medica is seeking a Risk Adjustment Compliance Project Manager to lead compliance-focused initiatives ensuring accuracy and regulatory adherence for Risk Adjustment programs. You will collaborate across teams, manage audits, and develop policies aligned with CMS regulations...Regulatory3 days per week- Freudenberg Medical LLC is seeking an experienced professional in medical device design and development in Minnesota. The role focuses on anticipating regulatory challenges, proposing product and process improvements, and leading complex technical initiatives. The candidate...RegulatoryMedical device
$75k - $112.6k
...Overview About Cretex Medical Cretex Medical is a leading contract... ...assemblies for the medical device industry. Our customers... ..., and adherence to regulatory and customer... ...~ Advanced GD&T ~ Lean manufacturing ~ Lead... ...help you figure out a project and get it done right...RegulatoryMedical deviceHourly payContract workTemporary workWork at officeLocal area- ...Minnesota, is seeking a Risk Adjustment Compliance Project Manager. This role is responsible for ensuring the accuracy and regulatory compliance of Medica’s Risk Adjustment... ...risk adjustment. Responsibilities include leading compliance initiatives, managing audit activities...Regulatory
- Laborie Medical Technologies Corp in Minnetonka, MN is seeking a Medical Writer II to develop clinical and regulatory documents and presentations. This role involves collaboration with internal... ...experience and knowledge of medical device regulations. Laborie offers various...RegulatoryMedical device
- Adraxe Corporation is an innovative medical device startup focused on the design,... ...epilepsy. The Role The Quality Affairs Lead exists to build and own a lean, scalable Quality Management... ...control rigor, DHF integrity, and regulatory readiness for IDE and eventual PMA...RegulatoryMedical device
$39 - $42 per hour
...A leading medical device firm in Minnetonka is seeking a Production Supervisor to lead and develop team members while ensuring safety and quality standards in production. The ideal candidate has 3-5 years of leadership experience in a regulated manufacturing environment...Medical deviceHourly pay$100 per hour
...Notes from the manager: Medical Device experience is required. This... ...You are responsible for • Lead all quality elements of Design... ...and product DHF for design projects. • Drive Quality norms associated... ...issues. • Support the Regulatory Affairs department for submissions...RegulatoryMedical deviceLocal areaRemote work$100.9k - $151.3k
...Overview About Cretex Medical: Cretex Medical is a leading contract... ...assemblies for the medical device industry. Our... ...compliance with applicable regulatory requirements (e.g.,... ...initiatives using Lean and risk-based... ...s requirements ~ Project management skills...RegulatoryMedical deviceHourly payContract workTemporary workWork experience placementWork at officeLocal area- ...Chemist II supports product development, regulatory submissions, and commercialization... ...conducting long-term and accelerated testing of device components or drug-device combinations,... ...of pharmaceutical regulations and medical device regulations and standards ~ Knowledge...RegulatoryMedical deviceFlexible hours
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