Senior Manufacturing Engineer
About The Position
At Recor Medical, we are pioneering Ultrasound Renal Denervation (uRDN) therapy to treat hypertension, the leading cardiovascular risk factor in the world. With our Paradise™ uRDN System, we’re on a mission to provide the millions of people who suffer from hypertension with a non-drug and minimally invasive option to lower their blood pressure. Join us on our journey and make a meaningful impact on the lives of people around the globe. The Senior Manufacturing Engineer is a hands-on position in the operations department which will perform duties as a sustaining and NPI manufacturing engineer as well as focus on packaging and labeling activities.
Requirements
- Bachelor of Science degree in Engineering or related field with a minimum of 5 years in a regulated environment such as the medical device industry.
- 5 years of experience in global regulatory labeling and packaging requirements, including experience supporting new product introductions and implementing labeling updates across global markets.
- Proficiency with ERP systems and electronic label/UDI management tools
- Experience with disposable devices (Class II / III), preferably balloon catheters and sterile packaging.
- Strong collaboration skills with contract manufacturers and suppliers that include aligning goals, managing expectations, and ensuring adherence to specifications and timelines.
- Proficiency with statistical analysis tools (JMP, MiniTab).
- CAD experience (SolidWorks preferred).
- Self-motivated, action oriented and result oriented.
- Deep understanding of medical device processes and assembly knowledge to drive product yield and performance.
- Lean or Six Sigma experience (Green Belt a plus).
Nice To Haves
- Working knowledge of injection molded plastic components is a plus.
Responsibilities
- Collaborate closely with Production teams to provide sustaining engineering support, resolving product and process issues within a controlled cleanroom environment.
- Lead the development and lifecycle management of labeling content, including product labels, packaging labels, Instructions for Use (IFUs), inserts, and digital labeling.
- Ensure alignment with product design outputs and compliance with change control processes.
- Own the end-to-end labeling process—from concept development and artwork creation to print proofing, verification, and final release—utilizing tools such as ArtiosCAD, Adobe Illustrator, or equivalent platforms.
- Collaborate closely with Regulatory Affairs on packaging and labeling activities supporting regulatory submissions, product registrations, and global market expansion.
- Identify and drive production capacity improvements.
- Participate as an extended team member for new product introduction, including scaling up, stabilizing and transfer to alternate sites.
- Hands on development, qualification and implementation of new production systems integrating mechanics, electronics, and software.
- Identify, manage, and qualify alternate supply sources or new vendors.
- Hands on investigation and root cause analysis.
Benefits
- Equal Employment Opportunity
- Pre-Employment Requirement: background check and/or drug screen
- Radiation Safety Requirement: personal dosimetry badge, ongoing safety training
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What This Job Offers
Job Type
Full-time
Career Level
Senior
