We are partnering with a growing medical device organization that needs a strong Sr. Regulatory Affairs Specialist to be a key player in their team. You will work hand in hand with the Director of RA/QA to prepare U.S. and international submissions, provide support for market regulatory approvals, assist with internal audits, license renewals, and provide review and approval for product change management. A strong candidate will have leadership capabilities to assist in the development of current team members, and grow into Management level roles.
Requirements
Bachelor's Degree required, preferably in the biological sciences, chemistry or related science
6+ years of relevant experience in the medical device industry (Class I or II devices)
6+ years of experience preparing premarket or other regulatory submissions (510(k), PMA, Technical Dossiers, etc…
Global medical device regulations and submissions (EU, Canada, Australia, Asian countries, Latin American countries, and Middle Eastern countries)
SkyWater Search Partners is looking for an experienced Sales Applications Engineer for a client of ours in St. Paul. This would be a full-time, permanent opportunity with a growing and thriving manufacturing organization.
For full job description, please email: cthonn@skywatersearch.com
Must Haves:
Automation systems experience and knowledge
CAD or SolidWorks experience
Manufacturing/Packaging/Robotics background
Main Responsibilities:
Work cross-functionally with internal engineering and manufacturing teams, including staff working in their new state-of-the-art fabrication center
Create and review CAD and SolidWorks drawings based on customer specs
Voice and face of company, when dealing with customers
SkyWater is excited to be partnering with a middle-market public accounting firm to add a driven and motivated Tax Manager (Estate, Gift, Trust and Individual) to their team! This role (newly created!) will provide estate, gift, trust and individual tax expertise to a variety of clients.
SkyWater is excited to be partnering with a middle-market public accounting firm to add a driven and motivated International Tax Manager to their team! This role (newly created!) will partner with large, privately held U.S. multinational companies and foreign-owned companies with operations in the United States to be a resource in international tax areas, as well as providing solutions to the companies’ international tax needs.
SkyWater is excited to be partnering with a leading food distributor in Minneapolis to add a driven and motivated Senior Pricing Analyst to their team! This is truly an exciting time to join this company as the company 1) recently moved headquarters from Chicago to Minneapolis and are therefore building out their entire Finance team from scratch and 2) is looking to grow from $700M to $2B over the next five years through organic growth and acquisitions. Therefore, there is a ton of opportunity to grow and help shape the organization and the organization’s culture!
The ideal candidate is passionate, hard-working and motivated – someone who truly loves financial pricing and can hit the ground running on day one.
If you’re looking for an exciting and challenging opportunity to grow your pricing skills and drive the future of an organization, this position could be an exciting opportunity for you!
SkyWater Search Partners is looking for an experienced and analytical Controls Engineer for a great client of ours in St. Paul. This would be a full-time, permanent opportunity with a growing and thriving MN-based organization.
For full job description, please email: cthonn@skywatersearch.com
Job Requirements and Experience:
Machine Motion Development (10, 20 Turbo)
PLC Logic, Produce and Consume Integration
This organization has very complex processes that has to do with motion control and robotics, so experience within that type of environment is key.
Production floor experience – knowledge of CNC, 3D Laser and Automation machinery
SkyWater Search Partners is looking for an experienced Electrical Engineer for a great client in St. Paul. This would be a full-time, permanent opportunity with a growing and thriving MN-based organization.
For full job description, please email: cthonn@skywatersearch.com
Job Responsibilities:
Component spec, technical calculations, schematics for every machine they have
Design electrical systems within 3D SolidWorks – Panel and Component Layout
Working alongside Panel Build Shop, robotics and manufacturing
Must-Have's:
Regulatory experience – UL, safety standards, etc.
SkyWater Search Partners is looking for an Assistant General Counsel for an established manufacturing client in St. Paul. Our client is a 50+ year old company with over 750 employees nationally and is an industry leading, reputable “essential business” with a strong financial track record. As Assistant General Counsel, you will be working side by side with the executive leadership team to provide advice on all business matters having legal implications and making recommendations that have material impact on business growth and operations. The Assistant General Counsel is also Corporate Secretary and reports to the Board. Scope of legal matters include: Corporate, Regulatory, Labor Relations, Contracts and Acquisitions.
SkyWater Search Partners is looking for a Fabrication Center Manager to join a growing and thriving manufacturing organization in town. This would be a full-time, permanent opportunity leading a team of 40 in a brand new fabrication center space, expected to be completed in Mid-May.
For full job description, please email: cthonn@skywatersearch.com
We've been partnering with this MN-based company for the past 5 years and have been lucky to be part of their consistent and impressive growth during that time. They operate as an extremely innovative full-service organization, from concept and prototyping to machining, manufacturing and packaging.
Being deemed essential, they are experiencing even more of an increase in project workload, hence the need for a true leader in this role.
Job Requirements:
Four-year degree in management, engineering, or equivalent in manufacturing and at least four years of leadership experience, or a two-year technical degree with eight or more years of manufacturing supervision experience.
Knowledge of machine tools and processes: Computer Numerical Control (CNC), programming, speeds and feeds, Numerical Control (NC), 5-axis machining (preferred), set up reduction, Rapid Prototyping, Manual Machining, GD&T, inspection methods and equipment.
Proven management experience managing and supervising employees.
Experience interpreting financial statements and managing financial results.
Advanced knowledge and experience in Excel, Word, Outlook and other business system tools.
Excellent troubleshooting, problem-solving and root cause analysis skills.
Has excellent interpersonal communication skills including ability to communicate clearly and effectively (verbally and non-verbally) to individuals and groups, internally and externally, and to exchange ideas and convey detailed information accurately.
Works collaboratively, as a team member, to suggest ideas and resolve issues in a positive manner.
We are partnered with a young Medical Device company in St. Paul that is looking to add a Quality Engineer. This role will be 70% focused on their new product line, and 30% on their products already to market. If you enjoy being part of close knit team and making an impact at small company this could be the role for you!
S
visit us
601 Carlson Parkway | Suite 150
Minneapolis, Minnesota 55305
