Senior Process Development Engineer
2 weeks ago
DIRECT CANDIDATES ONLY, IF INTERESTED APPLY THROUGH JOB POST. NO DIRECT MESSAGES.
RECRUITERS: DO NOT CONTACT.
SUMMARY OF THE JOB
The Process Development Engineer designs, develops and optimizes manufacturing processes for design transfer to the production facility. Maximizes efficiency by analyzing equipment selection, characterization of process, process workflow, and fixture development. A Product Development Engineer optimizes parts, equipment, and tools needed to achieve manufacturing goals according to product specifications ahead of design transfer activities.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Evaluate current catheter manufacturing practices and identify those needing improvement.
- Lead process development and optimization activities with Design for Manufacturing in mind.
- Seamlessly interface between R&D and Manufacturing.
- Draft design transfer documentation for multiple lines.
- Analyze and design sequence of operations and workflow to improve efficiencies and establish methods for maximum utilization of production facilities and personnel.
- Use Lean Manufacturing Methodology, including Value Stream Mapping and Kaizen events.
- Use Six Sigma Methodology (DMAIC or DMADV) and tools including Minitab, FMEA, Fishbone, Process Mapping, etc.
- Responsible for manufacturing process development, implementation, and continuous improvement to enhance yield, reduce cost and operator dependency.
- Represent Process Engineering in assigned R&D and Project Team meetings for technology transfers and provide technical expertise and support in analytical method development, validation and process scale, and current production capabilities in manufacturing.
- Performs or manages process validations (IQ/OQ, OQ, PQ).
- Troubleshoot production line issues related to yield, quality, and throughput.
- Leads scaling up processes from development to full scale manufacturing.
- Creates/Updates manufacturing instructions, routings, bills of materials and SOPs.
REQUIRED EDUCATION/TRAINING and/or EXPERIENCE:
- Bachelor's degree in a scientific/engineering discipline; or equivalent combination of education and experience.
- Minimum 5 years of experience in medical device (catheter experience preferred).
- Minimum 5 years of Process Engineering experience.
- Working knowledge of mechanical design principles and FDA regulated medical device design controls a plus.
- Proficient in CAD software, preferably SolidWorks.
- Statistical analysis of raw data is required, proficiency in Minitab is preferred.
- Hands-on experience managing suppliers and/or contract manufacturers a plus.
- Familiarity with design control according to 21 CFR 820 or ISO 13485, engineering change orders (ECO), Corrective Actions and Preventive Actions (CAPA) preferred.
KNOWLEDGE, SKILLS AND ABILITIES:
- Proficient in Risk Management according to ISO 14971.
- Knowledge of ASME Y14.5 GD&T.
- Excellent interpersonal, communication, and documentation skills are required.
- Takes initiative and acts quickly to drive solutions.
- Strong interpersonal, organizational and communication skills.
- A flexible team player, focusing on shared goals with a positive results?oriented attitude.
-
Senior Process Development Engineer
1 month ago
Carlsbad, United States Bolt Medical Full timeDIRECT CANDIDATES ONLY, IF INTERESTED APPLY THROUGH JOB POST. NO DIRECT MESSAGES.RECRUITERS: DO NOT CONTACT.SUMMARY OF THE JOBThe Process Development Engineer designs, develops and optimizes manufacturing processes for design transfer to the production facility. Maximizes efficiency by analyzing equipment selection, characterization of process, process...
-
Senior Process Development Engineer
1 month ago
Carlsbad, United States Bolt Medical Full timeDIRECT CANDIDATES ONLY, IF INTERESTED APPLY THROUGH JOB POST. NO DIRECT MESSAGES.RECRUITERS: DO NOT CONTACT.SUMMARY OF THE JOBThe Process Development Engineer designs, develops and optimizes manufacturing processes for design transfer to the production facility. Maximizes efficiency by analyzing equipment selection, characterization of process, process...
-
Senior Process Development Engineer
1 month ago
Carlsbad, United States Bolt Medical Full timeDIRECT CANDIDATES ONLY, IF INTERESTED APPLY THROUGH JOB POST. NO DIRECT MESSAGES.RECRUITERS: DO NOT CONTACT.SUMMARY OF THE JOBThe Process Development Engineer designs, develops and optimizes manufacturing processes for design transfer to the production facility. Maximizes efficiency by analyzing equipment selection, characterization of process, process...
-
Senior Process Engineer
7 days ago
Carlsbad, United States Assystem Full timeCompany Description Assystem is an international company with one mission: accelerate the energy transition around the world. Every day, our 6,500 switchers located in 12 countries (Europe, Middle East, Pacific Asia & Africa) connect their six thousand billion neurons to tackle the task of the century: switching to low-carbon energy. We are a collective...
-
Senior Design Quality Engineer
1 month ago
Carlsbad, United States Surf Search Full timeWe are searching for a Senior Design Quality Engineer for a rapidly growing medical devices company. This well funded company has a strong pipeline of electromechanical medical devices in various development stages. The ideal candidate for Senior Design Quality Engineer will have a strong background in design fundamentals, has worked in both large and small...
-
Process Engineer
1 month ago
Carlsbad, United States CareerBuilder Full timeMissions We are seeking an experienced Process Engineer experienced in the life sciences industry to join our team. As a Process Engineer, you will play a key role in designing, optimizing, and overseeing processes to ensure the highest quality and efficiency in the production of multiple types of pharmaceutical products. Responsibilities Collaborate with...
-
Senior Design Quality Engineer
1 month ago
Carlsbad, United States Surf Search Full timeWe are searching for a Senior Design Quality Engineer for a rapidly growing medical devices company. This well funded company has a strong pipeline of electromechanical medical devices in various development stages. The ideal candidate for Senior Design Quality Engineer will have a strong background in design fundamentals, has worked in both large and...
-
Senior Product Development Engineer
2 weeks ago
Carlsbad, United States Gilero Full timeJob Purpose: Responsible for developing new medical devices Duties: Act as technical lead in the development of new products, primarily class I and class II single-use medical devices Lead Project Management activities such as budgets, resources, timelines, and deliverables Provide primary interface to customer for communication of project status and...
-
Senior Product Development Engineer
3 weeks ago
Carlsbad, United States Gilero Full timeJob Purpose:Responsible for developing new medical devicesDuties:Act as technical lead in the development of new products, primarily class I and class II single-use medical devicesLead Project Management activities such as budgets, resources, timelines, and deliverablesProvide primary interface to customer for communication of project status and plansDevelop...
-
Senior Product Development Engineer
3 weeks ago
Carlsbad, United States Gilero Full timeJob Purpose:Responsible for developing new medical devicesDuties:Act as technical lead in the development of new products, primarily class I and class II single-use medical devicesLead Project Management activities such as budgets, resources, timelines, and deliverablesProvide primary interface to customer for communication of project status and plansDevelop...
-
Senior Product Development Engineer
3 weeks ago
Carlsbad, United States Gilero Full timeJob Purpose:Responsible for developing new medical devicesDuties:Act as technical lead in the development of new products, primarily class I and class II single-use medical devicesLead Project Management activities such as budgets, resources, timelines, and deliverablesProvide primary interface to customer for communication of project status and plansDevelop...
-
Senior Product Development Engineer
3 weeks ago
Carlsbad, United States Gilero Full timeJob Purpose: Responsible for developing new medical devices Duties: Act as technical lead in the development of new products, primarily class I and class II single-use medical devices Lead Project Management activities such as budgets, resources, timelines, and deliverables Provide primary interface to customer for communication of project status and plans...
-
Senior Automation and Controls Engineer
5 days ago
Carlsbad, United States CDM Smith Full timeCDM Smith is seeking a Senior Automation and Controls Engineer with broad experience in the design and implementation of SCADA systems, controls and instrumentation in the process industries. The successful candidate will have excellent communication Controls Engineer, Controls, Automation, Engineer, Senior, Client Relations, Technology, Sales
-
Senior CQV Engineer
6 days ago
Carlsbad, United States MMR Consulting Inc Full timeBiopharmaceutical Senior CQV Engineer Previous Pharmaceutical/Biotech experience is mandatory for this role. MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical, and biotechnology industries in North America and globally. Its services include Engineering, Project Management, Validation and other Consulting services....
-
Senior Validation Engineer
1 month ago
Carlsbad, United States CareerBuilder Full timeDIRECT CANDIDATES ONLY, IF INTERESTED APPLY THROUGH JOB POST. NO DIRECT MESSAGES. RECRUITERS: DO NOT CONTACT. SUMMARY OF THE JOB As a Senior Validation Engineer, you will play a critical role in ensuring the quality and compliance of products by developing and implementing robust validation strategies. Your expertise will be essential in verifying and...
-
Senior CQV Engineer
2 weeks ago
Carlsbad, United States MMR Consulting Full timeBiopharmaceutical Senior CQV EngineerPrevious Pharmaceutical/Biotech experience is mandatory for this role.MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical, and biotechnology industries in North America and globally. Its services include Engineering, Project Management, Validation and other Consulting services. MMR’s...
-
Senior CQV Engineer
3 weeks ago
Carlsbad, United States MMR Consulting Full timeBiopharmaceutical Senior CQV EngineerPrevious Pharmaceutical/Biotech experience is mandatory for this role.MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical, and biotechnology industries in North America and globally. Its services include Engineering, Project Management, Validation and other Consulting services. MMR’s...
-
Senior CQV Engineer
3 weeks ago
Carlsbad, United States MMR Consulting Full timeBiopharmaceutical Senior CQV EngineerPrevious Pharmaceutical/Biotech experience is mandatory for this role.MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical, and biotechnology industries in North America and globally. Its services include Engineering, Project Management, Validation and other Consulting services. MMR’s...
-
Senior Nodejs Developer
6 days ago
Carlsbad, United States Integrated Specialty Coverages, LLC Full timeJob Summary : We are seeking a highly skilled and experienced Senior Node.js Backend Developer who will be responsible for developing robust APIs and micro-services, modernizing legacy systems, and ensuring the security and scalability of our applications. The ideal candidate will have proficiency in Nodejs development, extensive experience with AWS...
-
Senior Validation Engineer
2 months ago
Carlsbad, United States Bolt Medical, Inc Full timeDIRECT CANDIDATES ONLY, IF INTERESTED APPLY THROUGH JOB POST. NO DIRECT MESSAGES.RECRUITERS: DO NOT CONTACT.SUMMARY OF THE JOBAs a Senior Validation Engineer, you will play a critical role in ensuring the quality and compliance of products by developing and implementing robust validation strategies. Your expertise will be essential in verifying and...