- 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.
- 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.
- Proficient in Risk Management according to ISO
- 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 resultsoriented attitude.
-
Development Engineer for Mechanical Integration
3 weeks ago
Sapphire Solutions Carlsbad, United StatesWHAT WE ARE LOOKING FOR · As a Development Engineer (m/f/d), you will be responsible for the comprehensive mechanical integration of equipment sets into military vehicles in Carlsbad. · Your tasks will include, but are not limited to: · - Realization of customer-specific projects ...
-
Senior Test Development engineer
9 hours ago
Chipright Carlsbad, United StatesSenior Test Development Engineers · JOB DESCRIPTION: · Chipright seeks a highly motivated and experienced test development engineers to work in validating our French customer's latest design. Working on new product Test development of power controller devices, you will have the ...
-
Senior Product Development Engineer
3 weeks ago
Gilero Carlsbad, United StatesJob 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 delive ...
-
Alphatec Spine Carlsbad, United StatesJob Description · Job DescriptionUnder routine supervision, primarily responsible for the development of new products and/or the enhancement of existing products associated with Electromechanical technology platforms. Responsibilities include development of processes and bringing ...
-
Senior Software Engineer C# Development:
1 week ago
Akraya Carlsbad, United StatesPrimary Skills:C#, XAML, MVVM, WinUI, RestAPIs · Contract Type: W2 Only · Duration: 6+ months contract with possible extension · Location: Carlsbad, CA (Hybrid) · Pay Range:$ $65.54 per hour · Grow your skills by working with industry leaders · JOB RESPONSIBILITIES: · Devel ...
-
Product Development Engineer
1 week ago
TaylorMade Golf Carlsbad, United StatesThe Product Development Engineer in this role will focus on performance understanding and optimization for TaylorMade drivers, fairway woods and hybrids. This position will require a variety of skills and tools to analyze, test, design, and prototype Product Development, Developm ...
-
Product Development Engineer
1 week ago
TaylorMade Golf Carlsbad, United StatesThe Product Development Engineer in this role will focus on performance understanding and optimization for TaylorMade drivers, fairway woods and hybrids. This position will require a variety of skills and tools to analyze, test, design, and prototype modifications of existing des ...
-
Software Development Engineer
1 week ago
ViaSat Carlsbad, United StatesAbout us · One team. Global challenges. Infinite opportunities. At Viasat, we're on a mission to deliver connections with the capacity to change the world. For more than 35 years, Viasat has helped shape how consumers, businesses, governments and militaries around the globe comm ...
-
Test Development Engineer
3 weeks ago
Chipright Carlsbad, United StatesChipright seeks a highly motivated and experienced test engineer for our European customer to integrate V93000 semiconductor test systems and services into customers environment, deliver best performance and meet project deadlines. · Requirements: · Development, debug and optim ...
-
Software Development Engineer
2 weeks ago
ViaSat Carlsbad, United StatesAbout us: · One team. Global challenges. Infinite opportunities. At Viasat, were on a mission to deliver connections with the capacity to change the world. For more than 35 years, Viasat has helped shape how consumers, businesses, governments and militaries around the globe comm ...
-
Software Engineer, Developer Experience
2 days ago
Rockstar Games Carlsbad, United StatesAt Rockstar Games, we create world-class entertainment experiences. · A career at Rockstar Games is about being part of a team working on some of the most creatively rewarding and ambitious projects to be found in any entertainment medium. You would be welcomed to a dedicated an ...
-
CAD Automation Engineer/Developer
3 weeks ago
CRBRM Carlsbad, United StatesAbout Cerebrum · Cerebrum creates strong online identities by building fast, simple, robust, and accessible web apps. We love speed, accessibility, and don't take the easy way. · Role Job Description · We are seeking a skilled CAD Automation Engineer/Developer to join our softwa ...
-
Senior Process Development Engineer
2 weeks ago
Bolt Medical Carlsbad, United StatesDIRECT 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. Maximiz ...
-
Senior Product Development Engineer
2 weeks ago
Gilero Carlsbad, United StatesJob 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 deliverab ...
-
Alphatec Spine Carlsbad, United StatesUnder routine supervision, primarily responsible for the development of new products and/or the enhancement of existing products associated with Electromechanical technology platforms. Responsibilities include development of processes and bringing up Manufacturing, development of ...
-
Engineering Technician C
2 weeks ago
L3Harris Technologies Carlsbad, United States**Job Title: Engineering Test Technician C** · **Requisition ID**:10573** · **Job Location: Carlsbad, CA** · L3Harris' Communication Systems segment is currently seeking a Engineering Technician C to join our team on 1st shift. This position will be based at our Carlsbad, Califor ...
-
Vice President of Raw Materials
3 weeks ago
Vuori, Inc Carlsbad, United States**Company Description** · Vuori is re-defining what athletic apparel looks like: built to move and sweat in but designed with a casual aesthetic to transition into everyday life. We draw inspiration from an active coastal California lifestyle; an integration of fitness, creative ...
-
Quality Manager
3 weeks ago
BSA Service Corp Carlsbad, United StatesJob Summary: · The Quality Manager is responsible for ensuring the production of high-quality products and the delivery of defect-free items to our customers. They plan, organize, direct, and actively participate in daily quality control activities in alignment with ISO9001 stand ...
-
General Management
2 weeks ago
Thermo Fisher Scientific Carlsbad, United StatesWhen you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your car ...
-
Engineering Technician D
2 weeks ago
L3Harris Technologies Carlsbad, United States**Job Title: Engineering Test Technician D** · **Requisition ID**:11229** · **Job Location: Carlsbad, CA** · L3Harris' Communication Systems segment is currently seeking a Engineering Technician C to join our team on 1st shift. This position will be based at our Carlsbad, Califor ...
Senior Process Development Engineer - Carlsbad, United States - Bolt Medical
Description
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
REQUIRED EDUCATION/TRAINING and/or EXPERIENCE:
KNOWLEDGE, SKILLS AND ABILITIES:
