About Balt
Our purpose is to improve the lives of 150,000 patients in 2026.
Our story
Balt is a rapidly growing pioneer in an exceptional field. For 45 years, Balt has been leading the way - collaborating with physicians and institutions to develop elegant medical devices. Our products are being used by physicians across the world, and we have 13 offices in 11 countries – and counting.
We introduced one of the first neurovascular intervention devices in 1977 and now offer the world's broadest portfolio of medical devices for stroke. As the premier global neurovascular platform always seeking to expand beyond boundaries, we are now bringing our innovation to the peripheral vascular space.
We are proud of our mission, our people, and the incredible work we accomplish together as we empower physicians to save lives.
Why Join Balt? Join a passionate team, dedicated to making a difference.
- Working at Balt means giving meaning to your work! Pride is a strong part of our identity.
- We are a close-knit team, with strong mission, vision and values that guide our day-to-day.
- Recognition of work, respect, and our multicultural community are key aspects of the employee experience and contribute to our continued success.
- No matter the country, we take care of you.
Would you like to be part of our story? Don't hesitate, come and join us!
About this opportunity – Senior Process Development Engineer
Description:
Sr Process Development Engineer will create our market-leading portfolio of innovations. Combine the best experience with training and mentorship to move forward and bring the next generation of life-changing medical technology to patients worldwide.
Job Responsibilities:
You will actively participate in new product development teams with specific responsibility for developing robust and capable manufacturing processes, ensuring R&D and Operations needs and targets are incorporated into the plans and activities. You will participate on cross-functional development teams that manage projects from concept through commercialization and will have a central technical role within the project team. As a seasoned individual contributor, you will provide solutions to complex technical problems associated with processes and equipment using problem solving techniques and methodologies.
You will be involved in process innovation with emphasis on improving quality, reducing process variation, improving cycle time and various cost down initiatives. You will perform complex analysis and provide recommendations on process improvements.
You will participate in or lead Equipment and Process Development, Process Characterization and Process Qualification to support new product introduction. You will utilize functional excellence in process development including DFM, process characterization, equipment development, Lean and Six Sigma methodologies. You will drive results on project teams, through building relationships and strong technical decision making.
- Partner with Design Engineering to identify Design for Manufacturability and Assembly targets
- Partner with purchasing to ensure all needed materials procurement per process development/validation/training needs and the 1st year forecast
- Plan and coordinate the execution of process characterization and validation
- Successfully complete all the Process Development Engineering elements of the PDP by the milestone dates
- Partner with production to ensure all LMR builds and first 3 months of commercial builds completed on time
- Create all required documents (manufacturing processes, protocols, reports, etc.)
- Ensure process capability and yield targets are met
- Provide mentoring and direction to more junior technical staff
- Hands-on development of manufacturing processes
- Design, Develop and qualify (IQ) tooling / equipment
- Develop and qualify in-process test methods (TMV, test method validation)
- Present status of plans and projects to larger team • Develop requirements and procure equipment for manufacturing processes
- Lead small team(s) for process development or problem solving
Qualification Requirements:
- Bachelors degree in an engineering/technical discipline required
- Minimum of 5 years of relevant experience, or advanced degree with a minimum of 3 years relevant experience
Skills:
- Demonstrated problem solving leadership skills (A3 DMAIC, first principles, and DOE)
- History of successfully transferring projects to manufacturing
- Green Belt or Black Belt training/certification; Minitab skills (normality, capability, hypothesis test, DOE, gage R&R, etc.)
- Medical device catheter manufacturing experience
- Experience with polymer extrusion, reflow, thermal bonding, and adhesive bonding
- Process error proofing (poka-yoke) experience
- Fixture design and development
- Experience meeting time-bound objectives
- Demonstrated project planning and execution
- Good presentation skills
- Leadership and self-starter qualities
Pre-requisites / Job Experience:
- Experience developing and validating medical device manufacturing processes (IQ, OQ, PQ, and PPQ)
- Working knowledge of PFMECAs, sampling plans, normality assessment, and capability assessment
- Process validation protocol and report writing
- Class II or III medical device manufacturing experience
Physical Requirements:
Extended periods of sitting or speaking.
Light lifting.
Potential travel to other company sites
Heavy computer use.
Must adhere to the company’s safety practices by performing work safely and in accordance with established standards.
Work Environment:
Working conditions are normal for an office environment.
The above information on this description have been designed to indicate the general nature of work performed by employees within this position. This job description is only a summary of the typical functions of the job, not an exhaustive or comprehensive list of all possible responsibilities. tasks, and duties, and does not limit the assignment of additional duties for this position.
Balt Group is an Equal Employment Opportunity employer.
More information please go to www.baltgroup.com
Warning: There are job offer scams impersonating companies like Balt Group. Legitimate correspondence will only come from "@baltgroup.com" emails.
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Top Skills
What We Do
We are Balt.
Physician-inspired innovations. Patient-focused solutions.
For more than 45 years, Balt has been leading the way – collaborating with physicians and institutions to develop elegant neurovascular solutions. As the premier global neurovascular platform, always seeking to expand beyond boundaries, we are now bringing our innovation to the peripheral vascular space.
We introduced the first neurovascular intervention device in 1977. Now, we offer the world’s broadest portfolio of medical devices for ischemic and hemorrhagic stroke, as well as devices for peripheral embolization.
In 2015, we embarked on an ambitious journey and more than quintupled our revenue and workforce, and that was only the beginning. Now, the Balt family includes more than 700 talented team members at 13 sites in 11 countries around the world.
Be a part of our future: www.baltgroup.com
