Juneau, AK · On-site
... medical device OEMExpertise in lean manufacturing, SPC, ISO 13485, FDA/CE regulatory landscapesAdvanced degree in Engineering, Manufacturing, or related disciplineBenefitsW2 employees of Eliassen ...
Juneau, AK · On-site
... medical device OEMExpertise in lean manufacturing, SPC, ISO 13485, FDA/CE regulatory landscapesAdvanced degree in Engineering, Manufacturing, or related disciplineBenefitsW2 employees of Eliassen ...
Juneau, AK · On-site +1
You will own the Product Security process that includes both pre-market and post-market processes ... Guide teams to make decisions that balance business needs with medical device security objectives.
Juneau, AK · On-site +1
You will own the Product Security process that includes both pre-market and post-market processes ... Guide teams to make decisions that balance business needs with medical device security objectives.
Fairbanks, AK · On-site +1
You will own the Product Security process that includes both pre-market and post-market processes ... Guide teams to make decisions that balance business needs with medical device security objectives.
Fairbanks, AK · On-site +1
You will own the Product Security process that includes both pre-market and post-market processes ... Guide teams to make decisions that balance business needs with medical device security objectives.
Anchorage, AK · On-site +1
You will own the Product Security process that includes both pre-market and post-market processes ... Guide teams to make decisions that balance business needs with medical device security objectives.
Anchorage, AK · On-site +1
You will own the Product Security process that includes both pre-market and post-market processes ... Guide teams to make decisions that balance business needs with medical device security objectives.
A leading consulting firm is seeking a Process Development Consultant to support a medical device company in scaling catheter production. The role requires over 10 years of experience in ...
A leading consulting firm is seeking a Process Development Consultant to support a medical device company in scaling catheter production. The role requires over 10 years of experience in ...
Ensure compliance with medical device regulations and quality systems (e.g., ISO standards ... of materials, processes, and design for manufacturability. Experience in medical devices or ...
Ensure compliance with medical device regulations and quality systems (e.g., ISO standards ... of materials, processes, and design for manufacturability. Experience in medical devices or ...
Producing documentation to support medical device regulatory processes Who This Is For * Students graduating in 2025 or later with a Bachelor's degree in Computer Science, Software Engineering ...
Producing documentation to support medical device regulatory processes Who This Is For * Students graduating in 2025 or later with a Bachelor's degree in Computer Science, Software Engineering ...
Producing documentation to support medical device regulatory processes Who This Is For * Students graduating in 2025 or later with a Bachelor's degree in Computer Science, Software Engineering ...
Producing documentation to support medical device regulatory processes Who This Is For * Students graduating in 2025 or later with a Bachelor's degree in Computer Science, Software Engineering ...
Producing documentation to support medical device regulatory processes Who This Is For * Students graduating in 2025 or later with a Bachelor's degree in Computer Science, Software Engineering ...
Producing documentation to support medical device regulatory processes Who This Is For * Students graduating in 2025 or later with a Bachelor's degree in Computer Science, Software Engineering ...
Anchorage, AK · Remote
$28 - $48/hr
Jude, Boston Scientific, Biotronik, or Sorin programmers; tests device operating parameter settings ... Medical * Dental * Vision * Colonial Life Elective Benefits * Life Insurance * Profit Sharing 401K
Anchorage, AK · Remote
$28 - $48/hr
Jude, Boston Scientific, Biotronik, or Sorin programmers; tests device operating parameter settings ... Medical * Dental * Vision * Colonial Life Elective Benefits * Life Insurance * Profit Sharing 401K
Anchorage, AK · On-site
Identifies technical writing and medical device industry standards, processes, policies, practices, and tools including Standard Operating Procedures (SOP)s, industry best practices, style guides ...
Anchorage, AK · On-site
Identifies technical writing and medical device industry standards, processes, policies, practices, and tools including Standard Operating Procedures (SOP)s, industry best practices, style guides ...
... or device programming. This position utilizes specialized knowledge, judgment, and skills to ... Collects and/or reviews pertinent medical, historical, and medication information in order to ...
... or device programming. This position utilizes specialized knowledge, judgment, and skills to ... Collects and/or reviews pertinent medical, historical, and medication information in order to ...
$19.50 - $25/hr
... or device programming. This position utilizes specialized knowledge, judgment, and skills to ... Collects and/or reviews pertinent medical, historical, and medication information in order to ...
$19.50 - $25/hr
... or device programming. This position utilizes specialized knowledge, judgment, and skills to ... Collects and/or reviews pertinent medical, historical, and medication information in order to ...
... or device programming. This position utilizes specialized knowledge, judgment, and skills to ... Collects and/or reviews pertinent medical, historical, and medication information in order to ...
... or device programming. This position utilizes specialized knowledge, judgment, and skills to ... Collects and/or reviews pertinent medical, historical, and medication information in order to ...
... and process safety engineering challenges in the industry. We are actively seeking talented ... Medical, Prescription Drug, Dental, & Vision insurance * HSA, FSA, and Dependent Care FSA options
... and process safety engineering challenges in the industry. We are actively seeking talented ... Medical, Prescription Drug, Dental, & Vision insurance * HSA, FSA, and Dependent Care FSA options
... and process safety engineering challenges in the industry. We are actively seeking talented ... Medical, Prescription Drug, Dental, & Vision insurance * HSA, FSA, and Dependent Care FSA options
... and process safety engineering challenges in the industry. We are actively seeking talented ... Medical, Prescription Drug, Dental, & Vision insurance * HSA, FSA, and Dependent Care FSA options
Juneau, AK · On-site +1
$82K - $165K/yr
... an exciting Process Tuner Field Engineer opportunity for you with our Power and Water Solutions ... We provide a variety of medical insurance plans, with dental and vision coverage, Employee ...
Juneau, AK · On-site +1
$82K - $165K/yr
... an exciting Process Tuner Field Engineer opportunity for you with our Power and Water Solutions ... We provide a variety of medical insurance plans, with dental and vision coverage, Employee ...
Anchorage, AK · On-site
$80 - $110/hr
... device control element and standard logic; • Work with client teams to define and develop HMI ... production processes, systems, and new technologies; • Knowledge of project execution in ...
Quick apply
Anchorage, AK · On-site
$80 - $110/hr
... device control element and standard logic; • Work with client teams to define and develop HMI ... production processes, systems, and new technologies; • Knowledge of project execution in ...
Anchorage, AK · On-site
Overtime Guaranteed * Medical Insurance (Individual and Family) * Dental Insurance * Vision ... RFI process. * Identifies all piping systems required to be pressure tested, generates test ...
Anchorage, AK · On-site
Overtime Guaranteed * Medical Insurance (Individual and Family) * Dental Insurance * Vision ... RFI process. * Identifies all piping systems required to be pressure tested, generates test ...
Juneau, AK · On-site
$186K - $233K/yr
Oversee the functional design and configuration for core business processes including ... Demonstrated experience in a highly regulated industry (Pharmaceutical, Biotech, or Medical Device ...
Juneau, AK · On-site
$186K - $233K/yr
Oversee the functional design and configuration for core business processes including ... Demonstrated experience in a highly regulated industry (Pharmaceutical, Biotech, or Medical Device ...
$53.3K - $62.4K
2% of jobs
$62.4K - $71.5K
9% of jobs
$79.8K is the 25th percentile. Wages below this are outliers.
$71.5K - $80.6K
15% of jobs
$80.6K - $89.7K
18% of jobs
The median wage is $92.9K / yr.
$89.7K - $98.8K
17% of jobs
$98.8K - $107.9K
14% of jobs
$108.2K is the 75th percentile. Wages above this are outliers.
$107.9K - $117K
11% of jobs
$117K - $126.1K
6% of jobs
$126.1K - $135.3K
4% of jobs
$135.3K - $144.4K
3% of jobs
$144.4K - $153.5K
1% of jobs
$53.3K
$99.1K
$153.5K
A Process Engineer in Medical Devices typically requires a degree in engineering (such as chemical, biomedical, or mechanical engineering) and experience with manufacturing processes, quality systems, and regulatory compliance. Familiarity with tools like CAD software, statistical analysis programs, lean manufacturing techniques, and knowledge of standards such as ISO 13485 are common requirements. Strong problem-solving abilities, project management skills, and excellent communication facilitate successful interactions with cross-functional teams. These skills ensure efficient, high-quality, and compliant manufacturing processes critical to patient safety and company success.
As a Process Engineer in the medical device industry, you'll commonly work on projects such as optimizing manufacturing processes, implementing new technologies, and ensuring compliance with strict quality and regulatory standards. Your daily tasks may include designing and validating production methods, troubleshooting process issues, and collaborating closely with quality assurance, R&D, and production teams. You may also be involved in documentation, process scale-up for new products, and continuous improvement initiatives. The role is highly collaborative, requiring you to coordinate with both technical and non-technical staff to meet quality, efficiency, and regulatory goals.
A Process Engineer in the medical device industry is responsible for designing, implementing, and optimizing manufacturing processes to ensure efficiency, quality, and compliance with regulatory standards. They work to improve production procedures, troubleshoot issues, and develop new process technologies. Their role involves collaborating with cross-functional teams, such as design, quality, and regulatory, to ensure medical devices meet industry requirements. Additionally, they analyze data, validate processes, and support continuous improvement initiatives to enhance product reliability and manufacturing scalability.
Full-time
Medical, Dental, Vision, Life, Retirement
This job post has expired today. Applications are no longer accepted.
Process Development ConsultantAnywhereType: ContractCategory: ManufacturingIndustry: Life SciencesWorkplace Type: RemoteReference ID: JN-042026-106275Date Posted: 04/05/2026DescriptionA growing medical device company specializing in steerable cardiac catheters is seeking an experienced Manufacturing Process Development & Scale-Up Consultant. Reporting to the CTO (Head of R&D & Operations), the consultant will lead efforts to transition low-volume manufacturing to outsourced, scalable production, including site selection, knowledge transfer, pilot implementation, and full-scale launch. Ideal candidates bring big-company, multi-step catheter manufacturing expertise and a proven track record in outsourced medical device scale-up.ResponsibilitiesOutsourced Manufacturer Selection & Onboarding Identify and evaluate potential US and global manufacturing partners capable of scaling catheter productionConduct site visits, due diligence, and comparative assessments for capacity, quality systems, and regulatory readinessSupport contracting, MSA negotiation, and alignment of manufacturing scopeKnowledge Transfer & Pilot Program Design Lead knowledge transfer sessions, ensuring clear documentation of current catheter assembly processesDevelop and manage pilot manufacturing protocols, including tolerances, throughput targets, and quality measuresSet success metrics and advance-to-production criteria for pilot outcomesScale-Up Planning & Execution Architect scalability roadmap: process flows, capacity planning, supply chain logistics, and automation potentialIntegrate quality systems, regulatory compliance, and process validation into scale-up transitionOversee supplier onboarding, staff training, and site readiness for production rampContinuous Improvement & Operations Enablement Implement statistical process control (SPC), lean manufacturing practices, and quality analyticsMonitor operational KPIs during pilot and early production phases and adjust protocols for improvementEnable cross-functional collaboration: Manufacturing, Quality, Supply Chain, R&D, and external partnersExperience Requirements10+ years in manufacturing process development, scale-up, and transfer in regulated medical device environments, preferably in catheters or steerable cardiovascular devicesProven success managing outsourced manufacturing startups, from pilot through annual production volume (~10k units/year)Strong familiarity with multi-step catheter assembly processes: extrusion, braiding, bonding, coating, final assemblyExperience conducting site qualification and knowledge transfers, driving pilot implementation and scaleDemonstrated ability to operate with objectivity and autonomy, ideal for high-ambiguity, scaling environmentsBackground at a large med-tech or medical device OEMExpertise in lean manufacturing, SPC, ISO 13485, FDA/CE regulatory landscapesAdvanced degree in Engineering, Manufacturing, or related disciplineBenefitsW2 employees of Eliassen Group who are regularly scheduled to work 30 or more hours per week are eligible for the following benefits: medical (choice of 3 plans), dental, vision, pre-tax accounts, other voluntary benefits including life and disability insurance, 401(k) with match, and sick time if required by law in the worked-in state/locality.Other employment options may be available that may result in pay outside of the provided range.EEO StatementEliassen is committed to building a diverse and inclusive team from a variety of backgrounds, perspectives, and skills.
We are an Equal Opportunity and Aff... [text truncated for brevity] ... and protected by federal, state, or local laws.J-18808-Ljbffr
Sourced by ZipRecruiter
Eliassen Group provides strategic consulting and talent solutions to drive our clients' innovation and business results. Our purpose is to positively impact the lives of our employees, clients, consultants, and the communities in which we operate. Leveraging over 30 years of success, our expertise in talent solutions, life sciences consulting, Agile consulting, cloud services, risk management, business optimization, and managed services enables us to partner with our clients to execute their business strategy and scale effectively. Headquartered in Reading, MA, and with offices from coast to coast, Eliassen Group offers local community presence and deep networks, as well as national reach.
It services
5,001 - 10,000 Employees
Reading, MA, US
1989
