Project Engineer - St Paul, United States - Konik Inc

Konik Inc St Paul, United States

3 weeks ago

Description

Project Engineer - Sustaining
Contract-to-Hire or Direct Hire | Saint Paul, MN | $80k-115k

Konik is partnering with a local manufacturing company that is seeking to add an engineer to their team.

This is an opportunity for an experienced engineer with a background in a medical device environment in project, continuation, quality, or research and development engineering.

If you are a highly organized engineer with an innate problem-solving and collaborative nature, please keep reading to see if this is the right opportunity for you.

In this role, you will be a key contributor with an ability to make a real impact.

What you would be doing:
Ensure products remain in conformance with regulatory requirements by developing test plans, protocols and reports
Maintain 1000's of products to State-of-the-Art
Act as project lead for FDA, MDR and CE Class I, II and III products
Provide effective communication of project plans, budgets, resources, and timeline
Perform gap analysis of relevant standards to determine actions needed to maintain technical documentation and declaration of conformance to state-of-the-art (Biocompatibility, Packaging, Sterilization, Reprocessing, Human Factors, etc.)
Oversee production sterilization activities to ensure products may be released to the market.
Author and maintain test plans, protocols and reports for Verification and Validation activities, applying appropriate statistical methodologies
Risk Management activities
Provide support with troubleshooting of manufacturing processes or product issues with manufacturing partners.
Documentation in compliance with ISO 13485 and FDA 820 quality systems, including design control
Apply knowledge of ASME Y14.

100:2017 Engineering Drawing Practices for creating and maintaining engineering drawings using appropriate tolerances considering design needs and manufacturing process capabilities.

What you have:
Bachelor's degree in Engineering or related science field
5+ years of experience in medical device is required
Knowledge of product conformance for the FDA, MDR, and CE Marking process
Technical Writing skills
AutoCAD and/or SolidWorks – or similar 2D and 3D drafting/modeling software
Knowledge of ISO 13485 requirements
Experience with various aspects of medical device development, such as human factors, biocompatibility, sterilization, packaging, etc
Strong problem-solving skills with a collaborative nature
Ability to lead cross-functional teams

Be the first to learn about future positions by joining our Newsletter and following us on LinkedIn

Konik is an equal-opportunity employer.

All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as a qualified individual with a disability, or any other protected class status.

Konik has been a leader in the technical staffing industry for more than 50 years, providing the fastest and easiest link between employees and employers.

Konik has specialized in placing professional, qualified personnel in Minnesota and western Wisconsin businesses since its inception and maintains a strong commitment to customer service.

#J-18808-Ljbffr

Project Engineer

2 weeks ago

Cps4jobs St Paul, United States

Project Engineer/Chemical Engineer/Mechanical Engineer/Engineering/Industrial Engineer/Food Manufacturing/Food Production/Senior Project Engineer/Project Engineering · Our client is a producer of ingredient solutions used in multiple industries. They are in search of a hands-on P ...
Project Engineer

3 weeks ago

Rudolph and Sletten St Paul, United States

Lunda Construction Co., a Tutor Perini Company, is seeking · Project Engineer · to join our office in · Rosemount, MN · with travel to project site in · Brandon, SD · About Lunda Construction: · Excellence in Construction since 1938 · Lunda Construction Co. is a major hea ...
Project Engineer

3 weeks ago

Big-D St Paul, United States

Big-D is looking for a dynamic Project Engineer. This is a great opportunity to start a career with a company that is on a mission to be the most sought-after company in the business. We seek and employee exceptional, hard-working, lifetime learners; we give them the tools to suc ...
Project Manager/Engineer

3 weeks ago

Excel Engineering St Paul, United States

Job Type · Full-time · Description · Excel Engineering, Inc. is seeking a team-oriented, highly motivated individual for a · Project Manager/Engineer · position. · In this position, this person will be managing and executing assigned projects from an Engineering Manager. Th ...
Sr. Project Engineer

1 week ago

Schwan's St Paul, United States

Who we are At Schwan's Company, the opportunities are real, and the sky is the limit; this isn't just a job, it's a seat at the table. Around here, every job matters, every voice counts, and every person contributes in a big way. As part of our front lines, we look to you to exec ...
Manager, Project Engineering

3 weeks ago

Aspen Technology St Paul, United States

Manager, Project Engineering page is loaded · Manager, Project Engineering · Apply · locations · Montreal - OSI · time type · Full time · posted on · Posted Yesterday · job requisition id · R5643 · The driving force behind our success has always been the people of Aspe ...
Civil Project Engineer

3 weeks ago

Bolton & Menk, Inc. St Paul, United States

Civil Project Engineer - Structural · CategoryEngineering · Description · Bolton & Menk has a great opportunity for a Structural Project Engineer to join our Structural Services Heavy Civil Structural Team in our Oakdale or downtown Minneapolis office. As a Star Tribune Top 20 ...
Senior Project Engineer

3 weeks ago

McDermott St Paul, United States

Job Description · Company Overview: · People power our future. That is why advancing a dynamic, inclusive environment, where everyone grows and thrives is critically important to us. · Our ingenuity fuels daily life. Together, we've forged some of the most trusted partnerships ...
Assistant Projects Engineer

3 weeks ago

State of Minnesota St Paul, United States

Working Title: Assistant Projects Engineer · Job Class: Engineer Senior · Agency: Transportation Dept · Who May Apply : Open to all qualified job seekers · Date Posted : 04/24/2024 · Closing Date : 05/21/2024 · Hiring Agency/Seniority Unit : Transportation Dept / DOT-Metro-Centra ...
Engineering Project Manager

3 weeks ago

E Tech Group St Paul, United States

Job Description · Job Description · At Automation Group, an · E Tech Group · company, joining our team means joining a group of passionate and forward-thinking experts. We're one of the largest engineering and system integration firms in the United States providing value for ...
Project Engineer

1 week ago

Trio Electric St Paul, United States

This is your opportunity to work alongside Project Managers and have a path to Project Manager (if you want it). You are more than just a number as our next · Project Engineer (Entry Level) · Project Engineer (Entry Level) · - What You Will Do · You will support our team of P ...
Project Engineer

2 weeks ago

Inland Rivers, Ports & Terminals, INC. St Paul, United States

ESSENTIAL FUNCTIONS OF THE JOB: · • Provide technical oversight and sign off on all engineered projects assigned to you. · • Communicate with customers and the sales department to clarify the desired outcome of a project. · • Be interactive with customer, by phone, in person or a ...
Project Engineer

2 weeks ago

Sportech St Paul, United States

Sportech is a rapidly growing company in Elk River, MN. We are looking for talented people who wish to join a values-based company that desires to help our people and customers win. We design, manufacture, and assemble cab components and systems for the powersports, golf and turf ...
project engineer

3 weeks ago

Randstad St Paul, United States

project engineer. · st paul , minnesota · posted 1 day ago · job details · summary · $ $72.86 per hour · contract · bachelor degree · category computer and mathematical occupations · reference · job details · job summary: · A Project Engineer is needed for a leading global ...
Structural Project Engineer II

1 week ago

HR Green St Paul, United States

Job Description · Job Description · Join our team Our mission is BUILDING COMMUNITIES. IMPROVING LIVES. With a history spanning over 110 years, HR Green has consistently delivered on this mission, establishing ourselves as a trusted partner for our colleagues, clients, and comm ...
Project Engineer

3 weeks ago

Novel Energy Solutions St Paul, United States

Project Engineer · Department: · Engineering · Employment Type: · Full Time · Location: · Minnesota · Description · The Project Engineer coordinates and manages outside engineering services to design and develop solar PV projects. · What you'll do: · Project Engineer track ...
Project Engineer

3 weeks ago

Konik Inc St Paul, United States

Project Engineer - Sustaining · Contract-to-Hire or Direct Hire | Saint Paul, MN | $80k-115k · Konik is partnering with a local manufacturing company that is seeking to add an engineer to their team. This is an opportunity for an experienced engineer with a background in a medi ...
Pavement Engineering Project Manager

1 week ago

Higher Recruitment INC St Paul, United States

Job Summary · The Project Manager is responsible and accountable for planning and allocating resources, preparing budgets, monitoring progress, and keeping stakeholders informed throughout the project lifecycle. The Project Manager leads a team of professionals in completing pro ...
Project Engineer

2 weeks ago

Randstad St Paul, United States

job summary: · A Project Engineer is needed for a leading global engineering, consulting and construction company in the Arden Hills, MN area. This position will work with R&D Design project teams to develop and execute on plans to create, verify, and validate new technology, pro ...
Project Engineer

3 weeks ago

Novel Energy Solutions St Paul, United States

Project Engineer · Department: Engineering · Employment Type: Full Time · Location: Minnesota · Description · The Project Engineer coordinates and manages outside engineering services to design and develop solar PV projects. · What you'll do: · • Project Engineer tracks and ...