Senior NPI Process Development Engineer
3 weeks ago
Job Overview
The Senior NPI (New Product Introduction) and Process Development Engineer plays a crucial role in maturing medical device products from prototype to market. This involves establishing and scaling assembly processes, influencing device design to ensure Design for Manufacturability (DFM), and collaborating with global cross-functional teams to define a competitive manufacturing strategy.
Responsibilities:
- Leads process development execution, from small-scale prototype production through to high-volume commercial readiness.
- Leverages experience in assembly tooling and technologies to support prototype production through high-volume manufacture, including fixture design, mold design, injection molding, bonding technologies, reagent integration, quality control methods, packaging, and more.
- Develops, implements, and qualifies complex or advanced assembly processes with a high level of expertise and confidence in DFM.
- Brings expertise on multiple technologies, such as laser welding, ultrasonic welding, heat staking, blisters, robotics, vision systems, and more, to inform optimal process development strategies.
- Resources, delegates, critiques, educates, and monitors technical work to satisfy project deliverables.
- Collaborates with Project Managers, New Product Development, Quality, Business Development, and Manufacturing teams.
- Communicates effectively with external clients, justifying process development objectives and manufacturing strategies through data-driven and risk-based approaches.
- Identifies risks to meet targeted COGS and champions solutions to recover.
- Generates project work proposals, including COGS, timeline, Capex, NRE, and NRT estimates, reflective of stage gate requirements and data collection activities.
- Initiates and manages capital equipment projects, including URS, FAT, and SAT activities, and works with strategic automation suppliers to customize equipment as needed.
- Generates and/or approves documentation to support Design History File (DHF) and Device Master Record (DMR).
- Utilizes statistical process control for product development and manufacturing optimization.
- Assists EH&S as needed and champions a safety-first process and team culture.
- Collaborates with Manufacturing sites to proactively plan for and support product transfer.
- Leverages lean methodologies, business acumen, and critical thinking to effectively scale and process improve workflows.
- May supervise direct reports.
- Travels as needed (domestic and international).
- Performs other duties as assigned.
Requirements:
- Bachelor's degree in engineering, manufacturing, or equivalent preferred.
- 5+ years of relevant engineering experience.
- Blister/Reagent Integration Technology experience required.
- Established, scaled, and improved production lines.
- Worked within an ISO 13485 regulated environment.
- SolidWorks experience preferred.
- Smartsheets experience preferred.
- Minitab experience preferred.
Competencies:
Values: Integrity, Accountability, Inclusion, Innovation, Teamwork
-
Senior NPI Process Development Engineer
3 weeks ago
Englewood, Colorado, United States TE Connectivity Full timeJob OverviewThe Senior NPI (New Product Introduction) and Process Development Engineer plays a crucial role in leading initiatives to mature medical device products from prototype to market. This involves establishing and scaling assembly processes, influencing device design to ensure Design for Manufacturability (DFM), and collaborating with global...
-
Senior Manufacturing Engineer
3 weeks ago
Englewood, Colorado, United States Actalent Full timeJob Title: Senior Manufacturing Engineer - Process Development ExpertJob Description:We are seeking a highly skilled Senior Manufacturing Engineer to join our team and lead the development of our manufacturing floor. The ideal candidate will have a strong background in process development and hands-on experience with precision electro-mechanical assembly,...
-
Manufacturing Engineer
4 weeks ago
Englewood, Colorado, United States Actalent Full timeJob Title:Senior Manufacturing EngineerJob Description:We are seeking a highly skilled Senior Manufacturing Engineer to join our team in Englewood, Colorado. As a key member of our manufacturing floor development team, you will be responsible for building out our manufacturing floor and leading the development of new processes.Key Responsibilities:Develop...
-
Senior Software Development Engineer
3 weeks ago
Englewood, Colorado, United States DISH Full timeJob SummaryWe are seeking a highly skilled Senior Software Development Engineer to join our team at DISH Network, LLC. As a key member of our data engineering team, you will be responsible for designing, developing, and maintaining large-scale data engineering pipelines and data warehouses.Key ResponsibilitiesCollaborate with business teams to provide...
-
Senior Land Development Engineer
4 weeks ago
Englewood, Colorado, United States RICK ENGINEERING COMPANY Full timeJob OverviewRICK Engineering Company is seeking a highly skilled Senior Land Development Engineer to join our team in Denver, CO. As a key member of our multi-disciplinary team, you will have the opportunity to work on meaningful, landmark projects in the Colorado region.Key Responsibilities:Develop and implement land development plans from conceptual design...
-
Senior Project Engineer
3 weeks ago
Englewood, Colorado, United States Amentum Full timeAmentum is seeking a highly skilled Senior Project Engineer to lead the technical execution of Engineering projects supporting our Environmental Management, Defense, National Security, and National Laboratory customers.This is a great opportunity for experienced professionals looking to transition their career from the Engineering Design track to the...
-
Senior Infrastructure Engineer
3 weeks ago
Englewood, Colorado, United States Innova Solutions Full timeJob Title: Senior Infrastructure EngineerAbout the Role:Innova Solutions is seeking a highly skilled Senior Infrastructure Engineer to join our team. As a Senior Infrastructure Engineer, you will be responsible for designing, implementing, and maintaining complex data center infrastructure solutions. You will work closely with our team to ensure that our...
-
Electrical Engineering Senior Position
3 weeks ago
Englewood, Colorado, United States SCRAM Systems Full timeElectrical Engineering Senior PositionAt SCRAM Systems, we are seeking a highly skilled Senior Electrical Engineer to join our team. As a key member of our engineering team, you will be responsible for leading and participating in new designs and sustaining efforts to maintain and improve the performance and reliability of our wearable consumer electronics...
-
Senior Manager of Engineering
4 weeks ago
Englewood, Colorado, United States Dairy Farmers of America Full timeJob Title: Senior Manager of EngineeringMeadow Gold is seeking a highly skilled Senior Manager of Engineering to lead our engineering services team. As a key member of our operations team, you will be responsible for ensuring the delivery of engineering services to our assigned plant.This role provides leadership and direction in assessing, determining, and...
-
Senior Satellite Manufacturing Engineer
3 weeks ago
Englewood, Colorado, United States General Atomics and Affiliated Companies Full timeAt General Atomics and Affiliated Companies, we are seeking a highly skilled Senior Satellite Manufacturing Engineer to join our Electromagnetic Systems (EMS) Group.The EMS Group focuses on the military and commercial applications of advanced electromagnetic technologies, including power generation and distribution, magnetic levitation, laser and weapons...
-
Senior Electrical Engineer
4 weeks ago
Englewood, Colorado, United States City Light & Power, Inc. Full timeJob DescriptionCity Light & Power, Inc. is seeking a highly skilled Senior Electrical Engineer to join our team. As a key member of our engineering team, you will be responsible for designing and developing electrical systems for our clients.Key Responsibilities:Design and develop electrical systems for substations, switching stations, and...
-
Senior Electrical Engineer Position
3 weeks ago
Englewood, Colorado, United States City Light & Power, Inc. Full timeAbout the Position:We are seeking a highly skilled Senior Electrical Engineer to join our team at City Light & Power, Inc. As a Senior Electrical Engineer, you will be responsible for designing and developing electrical systems, including sub-transmission systems, substations, and distribution systems.Key Responsibilities:Design and develop electrical...
-
Senior Data Center Engineer
4 weeks ago
Englewood, Colorado, United States Innova Solutions Full timeJob Title: Senior Data Center EngineerWe are seeking a highly skilled Senior Data Center Engineer to join our team at Innova Solutions. As a key member of our infrastructure team, you will be responsible for designing, implementing, and managing our data center infrastructure.Key Responsibilities:Design and implement data center infrastructure solutions,...
-
Senior Cloud Software Developer
3 weeks ago
Englewood, Colorado, United States Rincon Research Corp Full timeJob DescriptionRincon Research Corporation is seeking a highly skilled Senior Cloud Software Developer to join our team of innovators in Centennial, CO.This position involves designing and implementing cutting-edge software solutions for national security and defense signal processing, geolocation, and communication problems.The ideal candidate will have a...
-
Senior Java Software Engineer
4 weeks ago
Englewood, Colorado, United States TWO95 International Full timeJob Title: Senior Java Software EngineerJob Summary: We are seeking a highly skilled Senior Java Software Engineer to join our team at TWO95 International. The successful candidate will be responsible for developing and reviewing test protocols for our applications, as well as providing technical mentoring to developers and software architects.Key...
-
Senior Manager, Software Development Operations
4 weeks ago
Englewood, Colorado, United States Spectrum Full timeJob SummaryAs a Senior Manager, Software Development Operations, you will be responsible for providing direction and leadership to designated staff. You will develop and maintain test environments, integration strategies, and oversee Development Operations initiatives. You will coordinate and collaborate with Design, Architecture, Development, Test, and...
-
Senior Design Engineer
4 weeks ago
Englewood, Colorado, United States ENTRUST Solutions Group Full timeJob SummaryWe are seeking a highly skilled Senior Design Engineer - Transmission Line to join our team at ENTRUST Solutions Group. As a key member of our engineering team, you will be responsible for the design of high voltage electric transmission lines and/or distribution.Based out of the Englewood, CO area, you will work proficiently with software...
-
Senior Systems Engineer
3 weeks ago
Englewood, Colorado, United States Unavailable Full timeJob SummaryAs a Senior Systems Engineer at CommonSpirit Health, you will play a critical role in designing, building, and customizing ServiceNow applications and services. This position requires a strong understanding of infrastructure and relative technologies, as well as proven abilities in problem management, process analysis, and root cause analysis.Key...
-
Senior Wireless Network Engineer
4 weeks ago
Englewood, Colorado, United States Omni Inclusive Full timeJob Summary:Omni Inclusive is seeking a highly skilled Senior Wireless Network Engineer to join our team. As a key member of our engineering team, you will be responsible for designing, implementing, and testing wireless network solutions. Your expertise in wireless communication protocols, networking, and security will be crucial in ensuring the success of...
-
Senior Mechanical Design Engineer
4 weeks ago
Englewood, Colorado, United States SCRAM Systems Full timeJob Summary:As a Senior Mechanical Design Engineer at SCRAM Systems, you will be responsible for designing new products and enhancing current products. You will work directly with mechanical and electrical engineers, technicians, manufacturing, and quality functions to ensure seamless collaboration and efficient product...