... medical device manufacturing environment. This role will partner closely with R&D, Product Development, Manufacturing Engineering, Quality, and Operations teams to ensure products are designed for ...
60 Katalyst Medical Research Jobs Hiring Near You
... medical device manufacturing environment. This role will partner closely with R&D, Product Development, Manufacturing Engineering, Quality, and Operations teams to ensure products are designed for ...
... medical device products across sports medicine and soft tissue repair. This individual will work cross-functionally with product design engineering, manufacturing, regulatory affairs, marketing, R&D, ...
... medical device products across sports medicine and soft tissue repair. This individual will work cross-functionally with product design engineering, manufacturing, regulatory affairs, marketing, R&D, ...
... medical device products across sports medicine and soft tissue repair. This individual will work cross-functionally with product design engineering, manufacturing, regulatory affairs, marketing, R&D, ...
... medical device products across sports medicine and soft tissue repair. This individual will work cross-functionally with product design engineering, manufacturing, regulatory affairs, marketing, R&D, ...
Collaborate with R&D, Product Development, Quality, and Operations teams on NPI and Design Transfer ... Medical Device / Pharmaceutical Manufacturing. * Quality & Regulatory Compliance. * Engineering ...
Collaborate with R&D, Product Development, Quality, and Operations teams on NPI and Design Transfer ... Medical Device / Pharmaceutical Manufacturing. * Quality & Regulatory Compliance. * Engineering ...
Collaborate with R&D, Product Development, Quality, and Operations teams on NPI and Design Transfer ... Medical Device / Pharmaceutical Manufacturing. * Quality & Regulatory Compliance. * Engineering ...
Collaborate with R&D, Product Development, Quality, and Operations teams on NPI and Design Transfer ... Medical Device / Pharmaceutical Manufacturing. * Quality & Regulatory Compliance. * Engineering ...
Collaborate with R&D, Product Development, Quality, and Operations teams on NPI and Design Transfer ... Medical Device / Pharmaceutical Manufacturing. * Quality & Regulatory Compliance. * Engineering ...
Collaborate with R&D, Product Development, Quality, and Operations teams on NPI and Design Transfer ... Medical Device / Pharmaceutical Manufacturing. * Quality & Regulatory Compliance. * Engineering ...
Collaborate with suppliers, Research & Development, and Design Assurance teams to ensure products ... Ensure compliance with Medical Device Regulations, cGMP, CFR 820, ISO 13485, ISO 14971, ISO 9001 ...
Collaborate with suppliers, Research & Development, and Design Assurance teams to ensure products ... Ensure compliance with Medical Device Regulations, cGMP, CFR 820, ISO 13485, ISO 14971, ISO 9001 ...
Collaborate with cross-functional teams (R&D, Quality, Manufacturing) Education & Experience: * 5+ years of experience in mechanical design (medical device preferred) * Strong expertise in 3D stack ...
Collaborate with cross-functional teams (R&D, Quality, Manufacturing) Education & Experience: * 5+ years of experience in mechanical design (medical device preferred) * Strong expertise in 3D stack ...
Collaborate with R&D, Product Development, Quality, and Operations teams on NPI and Design Transfer ... Medical Device / Pharmaceutical Manufacturing. * Quality & Regulatory Compliance. * Engineering ...
Collaborate with R&D, Product Development, Quality, and Operations teams on NPI and Design Transfer ... Medical Device / Pharmaceutical Manufacturing. * Quality & Regulatory Compliance. * Engineering ...
Manufacturing Engineer
$81K - $104K/yr
Work with cross functional teams as required, especially with R&D, Quality, and Regulatory teams ... Previous medical device experience * 5+ years of Medical device Manufacturing experience
Manufacturing Engineer
$81K - $104K/yr
Work with cross functional teams as required, especially with R&D, Quality, and Regulatory teams ... Previous medical device experience * 5+ years of Medical device Manufacturing experience
... R&D, or manufacturing (including CTD Module 3 preparation) * Recent experience with Class III implantable medical devices and authoring/submission of PMA supplements * Knowledge of FDA PMA guidance ...
... R&D, or manufacturing (including CTD Module 3 preparation) * Recent experience with Class III implantable medical devices and authoring/submission of PMA supplements * Knowledge of FDA PMA guidance ...
Collaborating with R&D, manufacturing, and process development teams on electrical and mechanical ... Experience working in medical device or a similar GMP environment. * Ability to work with cross ...
Collaborating with R&D, manufacturing, and process development teams on electrical and mechanical ... Experience working in medical device or a similar GMP environment. * Ability to work with cross ...
Engr 2, Quality
$61K - $78K/yr
Coordinate and collaborate with Quality partners, R&D, Regulatory, Clinical Affairs, Marketing, and ... Preferred: * 1-3 years experience in Post-Market Surveillance in the medical device industry
Engr 2, Quality
$61K - $78K/yr
Coordinate and collaborate with Quality partners, R&D, Regulatory, Clinical Affairs, Marketing, and ... Preferred: * 1-3 years experience in Post-Market Surveillance in the medical device industry
Manufacturing Engineer
$75K - $96K/yr
Work with cross functional teams as required, especially with R&D, Quality, and Regulatory teams ... Previous medical device experience * 5+ years of Medical device Manufacturing experience
Manufacturing Engineer
$75K - $96K/yr
Work with cross functional teams as required, especially with R&D, Quality, and Regulatory teams ... Previous medical device experience * 5+ years of Medical device Manufacturing experience
Quality Engineer
$80K - $103K/yr
... R&D on quality initiatives. Requirements: * Bachelor's degree in Engineering, Biomedical Engineering, or a related field. * 0-3 years of experience in Medical Devices, Pharma, Biotech, or other ...
Quality Engineer
$80K - $103K/yr
... R&D on quality initiatives. Requirements: * Bachelor's degree in Engineering, Biomedical Engineering, or a related field. * 0-3 years of experience in Medical Devices, Pharma, Biotech, or other ...
As the technical lead, you'll work with R&D, Quality, Operations, and Regulatory team members to ... Roles & Responsibilities: * -Working with Medical Device OEM, sub-system and component suppliers to ...
As the technical lead, you'll work with R&D, Quality, Operations, and Regulatory team members to ... Roles & Responsibilities: * -Working with Medical Device OEM, sub-system and component suppliers to ...
Working with Medical Device OEM, sub-system and component suppliers to identify supplier ... Partnering with R&D, Design Assurance, Manufacturing Engineering, Operations Quality, and Project ...
Working with Medical Device OEM, sub-system and component suppliers to identify supplier ... Partnering with R&D, Design Assurance, Manufacturing Engineering, Operations Quality, and Project ...
Manufacturing Engineer
$77K - $99K/yr
Collaborate with Engineering, Quality, Operations, and R&D teams to support manufacturing and validation activities. * Produce audit-ready documentation in compliance with ISO standards and medical ...
Manufacturing Engineer
$77K - $99K/yr
Collaborate with Engineering, Quality, Operations, and R&D teams to support manufacturing and validation activities. * Produce audit-ready documentation in compliance with ISO standards and medical ...
Experience with infusion pump systems or similar electromechanical medical devices is preferred ... Collaborate with cross-functional teams including R&D, Quality, Regulatory, Manufacturing, and ...
Experience with infusion pump systems or similar electromechanical medical devices is preferred ... Collaborate with cross-functional teams including R&D, Quality, Regulatory, Manufacturing, and ...
High-level understanding of Biostatistics, Clinical, Discovery, Medical Affairs, Pharmacovigilance, Regulatory Affairs, RPA GxP BOTs, R&D AI GxP Education & Experience : * Bachelor of Science OR ...
High-level understanding of Biostatistics, Clinical, Discovery, Medical Affairs, Pharmacovigilance, Regulatory Affairs, RPA GxP BOTs, R&D AI GxP Education & Experience : * Bachelor of Science OR ...
Katalyst Jobs Information
What is it like to work at Katalyst?
Katalyst appears to be a collaborative and innovative company that values creativity and teamwork, fostering an environment where employees can share ideas and work together to achieve common goals.
The company's structure and work environment seem to be designed to support a dynamic and agile approach, with a focus on delivering high-quality results and driving business growth. Katalyst's mission is centered around helping businesses and organizations succeed through strategic partnerships and tailored solutions.
Working at Katalyst may appeal to individuals who are passionate about innovation, collaboration, and making a meaningful impact in their industry, as the company offers opportunities for professional growth, skill development, and contributions to a dynamic and forward-thinking organization.
The company's structure and work environment seem to be designed to support a dynamic and agile approach, with a focus on delivering high-quality results and driving business growth. Katalyst's mission is centered around helping businesses and organizations succeed through strategic partnerships and tailored solutions.
Working at Katalyst may appeal to individuals who are passionate about innovation, collaboration, and making a meaningful impact in their industry, as the company offers opportunities for professional growth, skill development, and contributions to a dynamic and forward-thinking organization.
What makes Katalyst an attractive place to work?
Katalyst is a forward-thinking company that has established itself as a leader in its industry, known for its commitment to innovation and customer satisfaction. The company's work environment is characterized by a collaborative and dynamic atmosphere, where employees are encouraged to share ideas and work together to drive progress. Joining Katalyst offers opportunities for professional growth and development, as well as the chance to contribute to meaningful projects that can have a lasting impact.
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What are the most popular jobs at Katalyst?
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Job description
Job Description:
We are seeking a highly experienced Staff Process Development Engineer to lead manufacturing process development activities supporting new product development (NPD), product design changes, and technology transfer within a regulated medical device manufacturing environment. This role will partner closely with R&D, Product Development, Manufacturing Engineering, Quality, and Operations teams to ensure products are designed for manufacturability, assembly, scalability, and operational excellence.
We are seeking a highly experienced Staff Process Development Engineer to lead manufacturing process development activities supporting new product development (NPD), product design changes, and technology transfer within a regulated medical device manufacturing environment. This role will partner closely with R&D, Product Development, Manufacturing Engineering, Quality, and Operations teams to ensure products are designed for manufacturability, assembly, scalability, and operational excellence.
Responsibilities:
- Lead process development and industrialization activities for new product introductions (NPI), product enhancements, and manufacturing transfers.
- Collaborate with R&D and Product Development teams during concept, feasibility, design verification, and design transfer phases to ensure manufacturable product designs.
- Perform comprehensive DFMA (Design for Manufacturing & Assembly) assessments to optimize product architecture, assembly methods, cost, quality, and throughput.
- Conduct CAD-based Assembly Tolerance Requirement (ATR) analyses and tolerance stack-up evaluations to validate assembly robustness and product performance requirements.
- Develop manufacturing process strategies, assembly methodologies, tooling concepts, fixtures, and automation solutions to support scalable production.
- Define and establish Key Process Input Variables (KPIVs) and Key Process Output Variables (KPOVs) to ensure process capability, product quality, and manufacturing consistency.
- Design, execute, and analyze process characterization studies, DOE (Design of Experiments), capability assessments, and process validation activities.
- Lead Process Failure Mode and Effects Analysis (pFMEA) activities and implement effective risk mitigation plans throughout product lifecycle development.
- Develop manufacturing standards, best practices, and structured DFMA review processes to support stage-gate product development activities.
- Evaluate and improve existing manufacturing and assembly processes through Lean Manufacturing, Six Sigma, and continuous improvement methodologies.
- Support equipment selection, process qualification, process validation, and vertical start-up activities for new manufacturing lines.
- Establish process controls, monitoring strategies, and statistical methods to maintain long-term manufacturing performance.
- Review and modify detailed CAD models and engineering drawings to ensure compliance with manufacturing, assembly, tolerance, and quality requirements.
Required Qualifications:
- Bachelor's Degree with 10+ years of experience, or Master's Degree with 8+ years of experience in Process Development, Manufacturing Engineering, Product Development, or Advanced Manufacturing within Medical Device or other highly regulated industries.
- Extensive experience supporting New Product Development (NPD) and product commercialization activities.
- Strong expertise in Design for Manufacturing and Assembly (DFMA) methodologies.
- Hands-on experience performing Assembly Tolerance Analysis (ATR) and tolerance stack-up assessments.
- Advanced proficiency with CAD and SolidWorks for product and assembly development.
- Experience developing manufacturing processes, assembly systems, fixtures, tooling, and automation solutions.
- Strong knowledge of DFSS, DOE, Statistical Process Control (SPC), Process Capability Analysis, and Process Validation methodologies.
- Experience leading pFMEA, risk assessments, and process optimization initiatives.
- Demonstrated ability to work cross-functionally with R&D, Quality, Operations, Supply Chain, and Manufacturing teams.
- Experience within FDA-regulated, ISO 13485, or similarly regulated manufacturing environments preferred.
Preferred Qualifications:
- Medical device manufacturing experience.
- Automated assembly and high-volume manufacturing experience.
- Lean Manufacturing and Six Sigma certification.
- Technology transfer and global manufacturing support experience.
- Strong technical leadership, mentoring, and project management skills.