JenaValve Technology, Inc.
Principal Engineer, DS Process Development
JenaValve Technology, Inc., Irvine, California, United States, 92713
Principal Engineer, DS Process Development
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Principal Engineer, DS Process Development
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JenaValve Technology, Inc. Principal Engineer, DS Process Development
3 days ago Be among the first 25 applicants Join to apply for the
Principal Engineer, DS Process Development
role at
JenaValve Technology, Inc. Get AI-powered advice on this job and more exclusive features. Description
Principal Engineer I, DS Process Development Principal Engineer II, DS Process Development Principal Engineer III, DS Process Development
Description
Job Title
: Principal Engineer, DS Process Development
Principal Engineer I, DS Process Development Principal Engineer II, DS Process Development Principal Engineer III, DS Process Development
Supervisor/Manager Title:
Manager, DS Manufacturing
Job Description Summary:
Responsible for process development and manufacturing engineering activities. Act as an interface between R&D, pilot, and commercial manufacturing. Contributes to the Delivery System product life cycle. Optimization and development of new or current manufacturing processes
Job Responsibilities
Technical engineering support for delivery systems to ensure process and equipment are characterized and scaled by utilizing new technology and standard work. Lead/support equipment, tooling, and fixture design for development and production activities. Identify and implement manufacturing process improvements internally and at contract manufacturers. Analyze and resolve complex manufacturing and compliance issues (CAPA, non-conformances, audit observations, etc.). Lead short-term and long-term manufacturing process improvement activities. Partner with Quality and R&D Engineers to develop and implement critical manufacturing processes. Process development of manufacturing processes and validations (IQ/OQ/PQ) for new product introduction and continuous improvement. Provide root cause analysis investigations and development/implement corrective actions for component and device nonconformance. Managing key suppliers and working directly with contract manufacturers. Provide technical support for design qualifications, design transfer, activities for regulatory submissions, product and process development and implementation of design control documents, and approval of product/process change. Manage all manufacturing-related aspects of the project within a team. Develop training and documentation materials (e.g., work instructions) for development and production activities. Provide real time production line support.
Qualifications
Required Education and Experience:
A Bachelor of Science degree in Mechanical or Biomedical Engineering (or equivalent engineering degree) is required. Minimum of 12+ years’ experience in Manufacturing or R&D Engineering is required with a preference in delivery systems or catheters. Level I, II, III DOE. Must have experience in the use of CAD (SolidWorks) packages. Knowledge of equipment qualification (IQ/OQ/PQ) and design verification (including statistical techniques used) in the medical device industry or other regulated industries is required. Must have experience in designing and implementing fixturing from design concept to a clinical/commercial production line. Must have experience in implementing equipment from parameter/settings origin to the production line. Knowledge and experience in Work Instruction creation and implementation.
Skills And Abilities Required For This Job
Must have experience in the use of CAD (SolidWorks) packages. Must be able to work effectively and collaborate within cross-functional teams. Must be able to effectively articulate (verbally and in writing) results and conclusions to technical and non-technical personnel. Must have strong project management and documentation skills. Must take initiative and have the ability to conduct hands-on work. Must possess the ability to handle multiple tasks with high attention to detail.
Benefits And Perks
Competitive medical, dental, and vision plans. Generous paid time off and company holidays. 401(k) plan with company match. Collaborative, mission driven work environment!
Equal Employment Opportunity (EEO) Statement
JenaValve is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, gender identity, or sexual orientation.
Right to Work and E-Verify Statement
JenaValve participates in E-Verify. We verify the identity and employment eligibility of all new hires through an electronic database maintained by the U.S. government. Learn more at Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Engineering and Information Technology Industries Medical Equipment Manufacturing Referrals increase your chances of interviewing at JenaValve Technology, Inc. by 2x Sign in to set job alerts for “Process Development Engineer” roles.
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Join to apply for the
Principal Engineer, DS Process Development
role at
JenaValve Technology, Inc. Principal Engineer, DS Process Development
3 days ago Be among the first 25 applicants Join to apply for the
Principal Engineer, DS Process Development
role at
JenaValve Technology, Inc. Get AI-powered advice on this job and more exclusive features. Description
Principal Engineer I, DS Process Development Principal Engineer II, DS Process Development Principal Engineer III, DS Process Development
Description
Job Title
: Principal Engineer, DS Process Development
Principal Engineer I, DS Process Development Principal Engineer II, DS Process Development Principal Engineer III, DS Process Development
Supervisor/Manager Title:
Manager, DS Manufacturing
Job Description Summary:
Responsible for process development and manufacturing engineering activities. Act as an interface between R&D, pilot, and commercial manufacturing. Contributes to the Delivery System product life cycle. Optimization and development of new or current manufacturing processes
Job Responsibilities
Technical engineering support for delivery systems to ensure process and equipment are characterized and scaled by utilizing new technology and standard work. Lead/support equipment, tooling, and fixture design for development and production activities. Identify and implement manufacturing process improvements internally and at contract manufacturers. Analyze and resolve complex manufacturing and compliance issues (CAPA, non-conformances, audit observations, etc.). Lead short-term and long-term manufacturing process improvement activities. Partner with Quality and R&D Engineers to develop and implement critical manufacturing processes. Process development of manufacturing processes and validations (IQ/OQ/PQ) for new product introduction and continuous improvement. Provide root cause analysis investigations and development/implement corrective actions for component and device nonconformance. Managing key suppliers and working directly with contract manufacturers. Provide technical support for design qualifications, design transfer, activities for regulatory submissions, product and process development and implementation of design control documents, and approval of product/process change. Manage all manufacturing-related aspects of the project within a team. Develop training and documentation materials (e.g., work instructions) for development and production activities. Provide real time production line support.
Qualifications
Required Education and Experience:
A Bachelor of Science degree in Mechanical or Biomedical Engineering (or equivalent engineering degree) is required. Minimum of 12+ years’ experience in Manufacturing or R&D Engineering is required with a preference in delivery systems or catheters. Level I, II, III DOE. Must have experience in the use of CAD (SolidWorks) packages. Knowledge of equipment qualification (IQ/OQ/PQ) and design verification (including statistical techniques used) in the medical device industry or other regulated industries is required. Must have experience in designing and implementing fixturing from design concept to a clinical/commercial production line. Must have experience in implementing equipment from parameter/settings origin to the production line. Knowledge and experience in Work Instruction creation and implementation.
Skills And Abilities Required For This Job
Must have experience in the use of CAD (SolidWorks) packages. Must be able to work effectively and collaborate within cross-functional teams. Must be able to effectively articulate (verbally and in writing) results and conclusions to technical and non-technical personnel. Must have strong project management and documentation skills. Must take initiative and have the ability to conduct hands-on work. Must possess the ability to handle multiple tasks with high attention to detail.
Benefits And Perks
Competitive medical, dental, and vision plans. Generous paid time off and company holidays. 401(k) plan with company match. Collaborative, mission driven work environment!
Equal Employment Opportunity (EEO) Statement
JenaValve is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, gender identity, or sexual orientation.
Right to Work and E-Verify Statement
JenaValve participates in E-Verify. We verify the identity and employment eligibility of all new hires through an electronic database maintained by the U.S. government. Learn more at Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Engineering and Information Technology Industries Medical Equipment Manufacturing Referrals increase your chances of interviewing at JenaValve Technology, Inc. by 2x Sign in to set job alerts for “Process Development Engineer” roles.
Orange County, CA $59,625.00-$99,375.00 10 months ago Lake Forest, CA $70,000.00-$80,000.00 2 weeks ago Foothill Ranch, CA $97,909.08-$127,604.77 1 week ago Irvine, CA $95,000.00-$100,000.00 1 week ago Process Engineer / Industrial Engineer - Manufacturing
Irvine, CA $66,000.00-$102,350.00 3 days ago Process Engineer / Industrial Engineer - Manufacturing
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Irvine, CA $100,000.00-$140,000.00 1 week ago Irvine, CA $110,000.00-$130,000.00 1 month ago Project/Associate Air Quality Engineer/Scientist
Irvine, CA $70,000.00-$80,000.00 2 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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