Process Development Engineer

Posted 19 Days Ago
Be an Early Applicant
Irvine, CA
75K-85K Annually
Entry level
Healthtech • Manufacturing
The Role
The Process Development Engineer will develop manufacturing processes for medical devices, conduct process improvements, and support new product introduction activities.
Summary Generated by Built In

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.  

  1. Working at Balt means giving meaning to your work! Pride is a strong part of our identity.  
  2. We are a close-knit team, with strong mission, vision and values that guide our day-to-day.  
  3. Recognition of work, respect, and our multicultural community are key aspects of the employee experience and contribute to our continued success.  
  4. 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 – Process Development Engineer

Description:

Process Development Engineer I will work on our market-leading portfolio of innovations and to help advance 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 technical role within the project team. As an individual contributor, you will drive to get the tasks assigned to you to the completion on time

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 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.

  • 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
  • Coordinate the execution of process characterization and validation
  • Work with NPI team for all the Process Development Engineering elements of the PDP by the milestone dates
  • Provide line support for LMR builds and first 3 months of commercial builds
  • Work with NPI team to create all required documents (manufacturing processes, protocols, reports, etc.)
  • Work with NPI team to ensure process capability and yield targets are met
  • 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  
  • Ensure compliance with industry standards and regulations

Qualification Requirements:

  • Bachelors degree in an engineering/technical discipline required
  • 0 to 2 years of relevant experience, advanced degree will be a plus

Skills:

  • Strong understanding of engineering principles and manufacturing processes
  • Medical device catheter manufacturing experience is preferred
  • Experience using Solidworks
  • Ability to analyze data, identify problems, and develop solutions
  • Ability to communicate technical information clearly and effectively
  • Proficient in Microsoft Word, Excel, PowerPoint, Visio or similar applications is required
  • Fixture design and development
  • Experience meeting time-bound objectives
  • Comfortable working independently and cross-functionally as part of a team
  • Self-starter qualities

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 



Please be aware of a current job offer scam perpetrated through the use of the internet. The scammers frequently misappropriate and use a company’s log and photos to give the appearance of legitimacy. The scam preys upon those seeking employment and uses false and fraudulent offers of employment with employers, such as Balt Inc to steal from the victims. Balt believes that one of the best ways to put a stop to this scam is to make sure you are aware of it. Balt’s job recruitment process involves live communication: in person, telephone, and/or video interviews in most cases.


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Pay Range

$75,000$85,000 USD

Top Skills

Excel
Microsoft Powerpoint
Microsoft Visio
Microsoft Word
Solidworks
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The Company
HQ: Boston, Massachusetts
397 Employees
On-site Workplace
Year Founded: 1977

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

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