Project Engineer - Saint Paul, United States - Konik

Konik Saint Paul, United States

1 week ago

Description

We're Hiring: Project Engineer - Sustaining

Location: Saint Paul, MN
Salary: $80,000 - $115,000

Konik has teamed up with a local manufacturing firm in search of a savvy Project Engineer to enhance their squad. This role is a fantastic opportunity for a skilled engineer well-versed in the realm of medical devices and experienced in project management, quality assurance, or research and development engineering. If you're an engineer with top-notch organizational skills, a knack for problem-solving, and a collaborative spirit, keep diving into the details below to see if this job suits you. As a part of this team, your contributions will be pivotal and make a real difference.

Key Responsibilities:

Ensuring products comply with regulatory standards by creating test plans, protocols, and reports
Managing maintenance for numerous state-of-the-art products
Leading projects involving FDA, MDR, and CE Class I, II, and III products
Communicating project plans, budgets, and timelines effectively
Conducting gap analysis of pertinent standards to maintain technical documentation
Supervising production sterilization processes for market release
Developing and updating test plans, protocols, and reports for Verification and Validation tasks
Engaging in Risk Management activities
Assisting in troubleshooting manufacturing processes or product issues
Ensuring documentation compliance with ISO 13485 and FDA 820 quality systems
Utilizing knowledge of ASME Y14.100:2017 Engineering Drawing Practices for creating and maintaining engineering drawings using suitable tolerances

Requirements:

Bachelor's degree in Engineering or a related field
Minimum 5 years of experience in the medical device industry
Familiarity with FDA, MDR, and CE Marking compliance
Proficient in Technical Writing
Experience with AutoCAD and/or SolidWorks, or similar 2D and 3D modeling software
Knowledge of ISO 13485 standards
Background in various areas of medical device development
Strong problem-solving skills and team-oriented attitude
Ability to lead cross-functional teams effectively

Dive into future opportunities by subscribing to our Newsletter and connecting with us on LinkedIn at Konik.

Konik is an equal opportunity employer, fostering diversity and inclusion in the workplace. Applicants are considered based on their qualifications without discrimination on the basis of race, religion, gender, age, disability, or veteran status.

With over five decades of experience, Konik has been instrumental in bridging the gap between technical talent and top-notch employers. Specializing in sourcing skilled professionals for businesses in Minnesota and western Wisconsin, we prioritize delivering exceptional customer service.

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