About ECI ECIs mission is to be the global leader of professional consulting services for the life sciences industry.
Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges, and we take pride in providing them transformative solutions with distinctive, sustainable and long-term value.
ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects.
Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.
About the role As a Sr.
Design Quality Assurance Engineer, you will ensure that all requirements are met for the Product Lifecycle Process, Risk Management, Design Controls, and Usability Testing.
You will work in fast-paced cross-functional teams to maintain and support quality-engineering methodologies, systems, and practices that meet company, customer, and regulatory requirements.
What You'll Do Provide quality and compliance input to project teams for decisions and deliverables (e.g., Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Review, Design V&V, Usability Testing, Process Validation, and Labeling)Support Risk Management planning, updating and maintenance of the product risk documentation in compliance with regulatory standardsSupport Usability Engineering and planning documentation Support the implementation of effective quality assurance, process controls, statistical analyses, and metricsProvide key quality trending information and dataOffer quality and compliance input for post-market activities such as design changes, supplier auditing, and customer complaint investigationsIdentify, prioritize, communicate, and resolve quality issuesLead implementation activities for post-market surveillance, product feedback, and corrective and preventive action programsSupport internal and external audits What We Look For Bachelors Degree in Biomedical/ Mechanical/ electrical engineering or equivalent is preferredMinimum of 10+ years direct experience in medical device industryAbility to perform work accurately and thoroughlyAbility to communicate effectively in written and oral formExcellent report writing skills essential along with the ability to find a solution or deal proactively with work related problemsAbility to develop and sustain positive relationships with internal as well as external customersIdentifying creative and efficient solutions to engineering challenges, Translating customer requirements into workable product ideas and solutions.Good analytical and problem-solving skillsBroad and in-depth regulatory knowledge in medical device (Class II and III medical devices)Vast experience in writing/reviewing design control documents and compilation of DHFsExperience with Minitab Statistical software ECI is an equal opportunity employer.
All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law.
At the time of this posting, all candidates must be authorized to work in the U.S.
without the need for employment-based visa sponsorship now or in the future.
At the time of this posting, ECI will not sponsor applicants for U.S.
work visa status for this opportunity.
Senior Design Quality Assurance Engineer -Medical Device #1425 • Arden Hills, MN, US
Why Kendall Howard?We're a growing IT manufacturer with a no-nonsense attitude: stay humble, work hard, and take on challenges head-first.Around here, you won't just do your job - you'll be part of... Show more
Product Testers are wanted to work from home nationwide in the US to fulfill upcoming contracts with national and international companies.We guarantee 15-25 hours per week with an hourly pay of bet... Show more
Job TitleFounded in 1948, Memorial Blood Centers (MBC), operated by New York Blood Center Enterprises, is one of the largest community-based, nonprofit blood collection and distribution organizatio... Show more
Product Testers are wanted to work from home nationwide in the US to fulfill upcoming contracts with national and international companies.We guarantee 15-25 hours per week with an hourly pay of bet... Show more
Job Title:Manufacturing Engineer IILocation:Arden Hills, MN (Onsite)Duration:Long Term Contract to HirePay:$53 an hour or about $107,000 a yearCandidates must be authorized to work in the U.Positio... Show more
Our People & Places Solutions business - reinforces our drive to improve the lives of people everywhere and epitomizes the why of what we do - the tremendous positive impact and value our solut... Show more
Automation EngineerRemoteJob DescriptionCreates, reviews and maintains automated software test suites and tools.Coordinates and performs automation projects from initiation through delivery.Ensures... Show more
Product Testers are wanted to work from home nationwide in the US to fulfill upcoming contracts with national and international companies.We guarantee 15-25 hours per week with an hourly pay of bet... Show more
Quality Assurance Specialist I.Element has a current opening for a Quality Assurance Specialist I to join our team in Eagan, MN.The Quality Assurance Specialist I conducts Quality Assurance program... Show more
Product Testers are wanted to work from home nationwide in the US to fulfill upcoming contracts with national and international companies.We guarantee 15-25 hours per week with an hourly pay of bet... Show more
Paul, MN 55101 (Hybrid one day per week.Interviews will be conducted in-person.Ten (10) years experience in software quality assurance or software testing roles.Five (5) years of QA leadership expe... Show more
Key Accountabilities: (The broad spectrum of items that the role is ultimately held accountable for at the end of the day.Key Responsibilities: (The finer details of what the role is assigned for t... Show more
Senior Manager, Global Post Market Quality Systems.At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees... Show more
Koch Companies is looking for a skilled Diesel Technician II to join our Koch NationaLease team at our St.In this role, you'll perform advanced preventative maintenance, troubleshooting, and comple... Show more
Divisional Quality Manager, AerospaceJob LocationsUS-MN-St.PaulID2026-18380OverviewElement has an opportunity for an experienced Division Quality Manager to join its team of quality professionals.R... Show more
Quality Engineer, Hybrid Maplewood MN.M Health Care is now Solventum.At Solventum, we enable better, smarter, safer healthcare to improve lives.As a new company with a long legacy of creating break... Show more
You are applying for a position through Medix, a staffing agency.The actual posting represents a position at one of our clients.Job SummaryOur client is seeking a dedicated Quality Inspector respon... Show more
Our F500 Medical Device client has an exciting opportunity for a Senior Project Manager.Job Summary: This role manages the development and implementation of cross functional projects that support m... Show more
Hi Team,Role :Senior QA ManagerLocation :390 Robert Stree North, Saint Paul, MN ----(Hybrid) ---In person InterviewDuration :6MonthsJob DescriptionMinimum QualificationsTen (10) years' experience i... Show more
Insight Global is hiring Quality Receiving Inspectors to join a manufacturing operations team responsible for ensuring quality and compliance of incoming materials at a contract manufacturing medic... Show more
