Principal Engineer NPI
3 weeks ago
The Principal Engineer for New Products Integration (NPI) will lead projects through the product development process from working with the rest of the R&D team through feasibility and prototype building stages, through verification and validation and conduct transfer of design into production. The engineer will be responsible for development efforts in house as well as managing external design partners. Responsible for providing cross functional technical expertise to quality, operations, regulatory, marketing, and clinical groups utilizing sound judgement and engineering practices, while displaying intelligent, and smart leadership skills.
Responsibilities- Product development: Designs, builds, and tests products per 21CFR820 using design for manufacturing approach to mitigate risk and improve design. The scope includes leading simulations, fabrication, testing, as well as developing / creating product requirements, test plans/protocols and their execution.
- Project management: Work with design partners on device design and synchronizing with Merz project management to identify and execute necessary efforts to satisfy project objectives. Identify risks and create mitigations, review and discuss tooling and/or testing needs including, develop multiple contingency plans throughout the development process.
- Prototype manufacturing: Lead engineering prototype builds, including generating BOMs, ordering parts and materials, develop incoming inspection standards and training lab technicians as necessary. Work closely with product development, NPI, suppliers, and R&D to pilot manufacture product development and assembly efforts for new a device builds.
- Subject matter expert: Provide technical expertise to cross functional groups including operations, quality, regulatory, and clinical teams especially in technical explanation and root cause analysis.
- Documentation: Create and maintain accurate documentation throughout the design and development process per GDP and GMP.
- Test Methods: Involved is writing test plans, procedures, work instructions, rationales, memos, and data analysis as it relates to technical requirements and specifications. Involved in developing test equipment and methods to verify and/or validate tools or setup as required.
- Required Professional Experience:
- 7+years of related development experience in the medical device and/or electronics industry
- 5+ years' experience within R&D product development creating devices and/or adding product features that were successfully released
- 3+ years' experience mentoring and supervising other engineers and technicians
- Required Knowledge, Skills, and Abilities:
- Knowledge of design for manufacturing, from feasibility through transfer to production
- Familiarity with electrical or electronic characterization such as:(impedance, acoustic tank, pulse-echo, force balance, transmitting voltage response) ultrasound devices
- Strong familiarity with the product development process and proven capability leading verification and validation efforts for design transfer
- Ability to develop RFP, RFQ, and SOW for internal functional groups or outside vendors
- Common use of SolidWorks, Finite Element Analysis (FEA), Statistics or DOE techniques
- Design and development of new products, features which require orchestration of deliverables from multiple functional groups
- Considered subject matter expert in at least one engineering discipline (e.g. EE, SW, Ultrasound, Mechanical, etc.)
- Effective interpersonal skills enabling constructive communication with cross functional groups
- Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)
- Must be proficient in MS Word, Excel, and PowerPoint
- Familiarity with acoustic standards (IEC , IEC , 21CFR1050.10, MIL-STD-1376), ISO13485, 21 CFR 820:30.
- Education:
- Required: Bachelor's Degree in ME or EE or other relevant Engineering discipline
- Preferred: MBA / Master's in ME or EE or other relevant Engineering discipline
-
Senior NPI Engineering Specialist
1 week ago
Raleigh, North Carolina, United States Merz Aesthetics Full timeThe Lead Engineer for New Product Integration (NPI) will oversee projects throughout the product development lifecycle, collaborating with the R&D team during feasibility assessments and prototype creation, progressing through verification and validation stages, and facilitating the transition of designs into production. This role entails managing both...
-
Principal Transducer Engineer
3 weeks ago
Raleigh, North Carolina, United States Merz North America Full timeThe Principal Transducer Engineer will lead ultrasound transducer projects through the product development process from feasibility and prototype building through verification and transfer to production. The engineer will be responsible for transducer design efforts in house as well as managing external design partners. Responsible for providing cross...
-
Principal Mechanical Engineer
3 weeks ago
Raleigh, North Carolina, United States Merz North America Full timePrincipal mechanical engineers develop new products, redesign existing products, and perform research and testing on product concepts related to medical devices. This individual will be an important member of the Merz Advanced Development team focused on research, development, and bringing to market medical devices to support Merz business objectives. The...
-
Principal Tech Support Engineer
3 weeks ago
Raleigh, North Carolina, United States insightsoftware Full timeCompany Descriptioninsightsoftware is a global provider of reporting, analytics, and performance management solutions that unlock the potential of business data and transform the way finance and data teams operate. We empower leaders from over 32,000 organizations to make timely and intelligent decisions. Our comprehensive solutions span Financial Planning...
-
Principal Mechanical Engineer
4 days ago
Raleigh, North Carolina, United States Dewberry Full timeAbout DewberryDewberry is a leading professional services firm with a strong presence in the healthcare industry. Our team of experts provides innovative and complex solutions to clients across the country.Job SummaryWe are seeking a highly experienced Principal Mechanical Engineer to lead our healthcare design team in Raleigh, NC. As a key member of our...
-
Principal Mechanical Engineer
11 hours ago
Raleigh, North Carolina, United States Dewberry Full timeAbout DewberryDewberry is a leading professional services firm with a strong presence in the healthcare industry. Our team of experts provides innovative and complex solutions to clients across the country.Job SummaryWe are seeking a highly experienced Principal Mechanical Engineer to lead our healthcare design team in Raleigh, NC. As a key member of our...
-
Principal Mechanical Engineer
2 days ago
Raleigh, North Carolina, United States Saint-Gobain Full timeAbout the RoleWe are seeking a highly skilled Principal Mechanical Engineer to join our team at Saint-Gobain/CertainTeed. As a key member of our Project Management Office (PMO), you will be responsible for managing the development and safe implementation of equipment and installation packages within capital projects for our Roofing manufacturing plants.Key...
-
Chief Engineer for Product Integration
1 week ago
Raleigh, North Carolina, United States Merz Aesthetics Full timeThe Lead Engineer for New Product Integration (NPI) will spearhead initiatives throughout the product development lifecycle, collaborating with the R&D team during feasibility assessments and prototype creation, progressing through verification and validation, and overseeing the transition of designs into production. This role entails managing in-house...
-
Principal Electrical Engineer
1 week ago
Raleigh, North Carolina, United States WSP Full timeJoin Our Dynamic Team as a Senior Electrical EngineerThis role presents an exciting opportunity within WSP, a prominent firm recognized for its excellence in engineering services across various sectors. Become a vital member of our Properties & Buildings Team, dedicated to achieving client goals and navigating complex challenges.Your Responsibilities Will...
-
Principal Civil Engineer
1 week ago
Raleigh, North Carolina, United States Jobot Full timeJoin Jobot as a Lead Civil Engineer in Renewable EnergyWe are a prominent entity in the Renewable Energy sector seeking a Lead Civil Engineer to enhance our team. This position offers the flexibility of remote work for qualified candidates.Key Responsibilities: Conduct research to ensure adherence to local, state, and federal regulations for projects....
-
Principal Project Engineer
1 week ago
Raleigh, North Carolina, United States Heidelberg Materials US, Inc. Full timeJoin Our Team as a Senior Project Engineer at Heidelberg MaterialsPosition Summary: The Senior Project Engineer role at Heidelberg Materials is a vital position within our organization, offering engineering design, project oversight, and construction assistance across various operations. This position provides an excellent opportunity to engage with a...
-
Principal Civil Engineer
1 week ago
Raleigh, North Carolina, United States The Ladders Full timeCompany OverviewThe Ladders is a leading professional services firm that excels in engineering, planning, surveying, and environmental solutions. We cater to both public and private sector clients nationwide, fostering success through innovative and challenging projects.Position SummaryThe Senior Civil Engineer plays a pivotal role within our organization,...
-
Principal Project Engineer
1 week ago
Raleigh, North Carolina, United States Timmons Group Full timeCompany OverviewTimmons Group is a prominent engineering and technology firm, recognized nationally for its excellence and commitment to providing top-tier services. We pride ourselves on our diverse offerings, including civil engineering, environmental solutions, GIS/geospatial technology, and landscape architecture.Position OverviewWe are currently seeking...
-
Principal Electrical Engineer
1 week ago
Raleigh, North Carolina, United States TKDA Full timeJoin Our Dynamic TeamWe are a reputable employee-owned firm seeking a Senior Electrical Engineering Specialist with extensive expertise in technical design standards and requirements for industrial electrical systems.Role OverviewAs a vital member of our multidisciplinary team, you will collaborate with professionals across various engineering fields,...
-
Principal Software Engineer
1 week ago
Raleigh, North Carolina, United States Accentuate Staffing Full timeAccentuate Staffing is collaborating with a prominent industry leader seeking a Senior Software Engineer to enhance their development team. In this pivotal role, you will have the chance to play a key part in the evolution and modernization of essential systems. Your contributions will be vital in advancing technological innovations and optimizing...
-
Principal Electrical Engineer
4 days ago
Raleigh, North Carolina, United States The East Group Full timeSenior Electrical Engineer OpportunityThe East Group is seeking a highly skilled Electrical Engineer with over a decade of professional experience. This role offers the chance to engage in diverse projects of varying scales and complexities. Candidates are required to hold a valid professional engineering license in North Carolina and demonstrate strong...
-
Principal Structural Engineer
1 week ago
Raleigh, North Carolina, United States IMEG Corp Full timeElevate Your Career with IMEG CorpAt IMEG Corp, a leading design consulting firm in the United States, we are dedicated to offering fulfilling and dynamic career paths for our employees. Our team is passionate about their work, and we believe in maintaining a balance between professionalism and enjoyment. With over 2500 employee-owners, we foster a local...
-
Principal Engineer
1 week ago
Raleigh, North Carolina, United States Solvenow Inc. Full timePosition Overview:As a Lead Electrical Engineer at Solvenow Inc., you will play a pivotal role in our engineering team, focusing on the design and implementation of substation projects.Key Responsibilities:Substation Design: Serve as the technical lead for substation design initiatives, ensuring compliance with industry standards.Design Deliverables: Develop...
-
Principal Structural Engineering Specialist
1 week ago
Raleigh, North Carolina, United States EwingCole Full timeAbout EwingColeEwingCole is a distinguished firm specializing in architecture, engineering, interior design, and planning, recognized nationally for our commitment to excellence, innovative design, and collaborative practices.Position OverviewWe are seeking a Structural Project Engineer with a minimum of 8 years of experience to join our Structural Team....
-
Lead Mechanical Design Engineer
10 hours ago
Raleigh, North Carolina, United States Dewberry Engineers Incorporated Full timeAbout Dewberry Engineers IncorporatedDewberry Engineers Incorporated is a leading professional services firm with a strong presence in the healthcare industry. Our team of experts provides innovative and complex solutions for facilities and campus infrastructure projects.Job DescriptionWe are seeking a highly experienced Principal Mechanical Engineer to join...