- 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
-
Sr. Engineer, NPI
1 week ago
Merz North America Raleigh, United StatesSr. Engineer is a product development R&D, manufacturing, and process development skilled individual that is assigned project work related to manufacturing integration of medical devices from concept to start-up manufacturing. This individual will be involved in all phases of pro ...
-
NPI Product Development Engineer
4 days ago
Cree Durham, United StatesAt Wolfspeed, we do amazing things in a human way. · We know that the achievements of our organization are due to the passion, hard work and creativity of our employees. We celebrate different perspectives to foster excellence across our organization, and our goal is to make div ...
-
Process Control Engineer
1 week ago
ITC Raleigh, United StatesOur large manufacturing client located in Clayton, North Carolina, is looking for a Process Control Engineer, to add to their team. · Position's Contributions to Work Group: · Collaborate with category procurement teams and facilities on Assurance of supply initiatives, capacit ...
-
Strategic Sourcing Analyst
1 day ago
TeamBuilders Raleigh, United StatesSTRATEGIC SOURCING ANALYST · Job Responsibilities · Focal point of all procurement initiatives associated with your given productline(s) · Data Analysis for Key Performance Metrics and Operational items · Responsible for attaining annualbusiness results (ex. cost savings,suppli ...
-
Strategic Sourcing Analyst
2 days ago
ITech Consulting Partners Raleigh, United StatesFocal point of all procurement initiatives associated with your given productline(s) · Data Analysis for Key Performance Metrics and Operational items · Responsible for attaining annualbusiness results (ex. cost savings,supplier performance and compliance) for responsible product ...
-
Strategic Sourcing Analyst
2 days ago
Cameron Craig Group Raleigh, United StatesFocal point of all procurement initiatives associated with your given productline(s) · Data Analysis for Key Performance Metrics and Operational items · Responsible for attaining annualbusiness results (ex. cost savings,supplier performance and compliance) for responsible product ...
-
Manufacturing Engineer II
1 week ago
Jabil Circuit, Inc. Raleigh, United StatesRole Summary: · As a Manufacturing Engineer II at Jabil, you will play a vital role in advancing our manufacturing operations in CNC screw production. Your responsibilities encompass process development, tool design, machine programming, machinery & equipment acquisition, manufac ...
-
Senior Project Engineer
1 week ago
Hitachi Automotive Systems Americas Raleigh, United Stateslocations · Tarboro, North Carolina, United States of America · time type · Full time · posted on · Posted Yesterday · job requisition id · R0035836 · Location: · Tarboro, North Carolina, United States of America · Job ID: · R · Date Posted: · Company Name: · HITACHI ASTEMO ...
-
Assembly Laboratory Technician
1 week ago
Merz Pharmaceuticals USA Raleigh, United StatesThis position primary responsibility is to assemble and test prototypes products of Ulthera's ultrasonic products that are in R&D development. Assembly Laboratory Technician will provide and establish themselves as a subject matter expert to R&D engineers regarding the manufactur ...
-
Manufacturing Engineer
1 week ago
The Heico Companies Raleigh, United StatesJob Description Wakefield Thermal is part of the Heico Companies, and in the aggregate, Heico's businesses generate more than $3.2 billion in revenues. Wakefield Thermal is a global leader in innovative thermal management solutions for a diverse range of markets. Building on over ...
-
Manufacturing Engineer
2 days ago
Field Controls Raleigh, United StatesWakefield Thermal is part of the Heico Companies, and in the aggregate, Heico's businesses generate more than $3.2 billion in revenues. Wakefield Thermal is a global leader in innovative thermal management solutions for a diverse range of markets. Building on over four decades of ...
-
Engineering Manager
1 week ago
Commercial Vehicle Raleigh, United StatesThe Engineering Manager is responsible for overseeing and optimizing manufacturing processes within our plant. This position involves leading a team of engineers to drive continuous improvement initiatives, enhance productivity, ensure product quality, and maintain safety standar ...
-
Engineering Manager
1 week ago
Commercial Vehicle Raleigh, United StatesThe Engineering Manager is responsible for overseeing and optimizing manufacturing processes within our plant. This position involves leading a team of engineers to drive continuous improvement initiatives, enhance productivity, ensure product quality, and maintain safety standar ...
-
Zscaler Raleigh, United States**Sr. Services Excellence Learning Manager** · Raleigh, NC, USA · Employees can work remotely · Full-time · Department: Customer Services · **Company Description** · Zscaler (NASDAQ: ZS) accelerates digital transformation so that customers can be more agile, efficient, resi ...
-
Manufacturing Engineer
1 week ago
Novanta Raleigh, United StatesThank you for your interest in Novanta. You have taken the first step towards a new career opportunity. We invite you to complete your application. By taking this step, your information will be stored for future submissions to our open jobs according to Novanta's · Data Privacy ...
-
Director of Manufacturing
4 days ago
TARGAN Inc. Raleigh, United StatesJob Description · Job DescriptionDescription:This role is responsible for the application of technology and operational excellence in all manufacturing processes for both new product introduction and in support of existing products that are produced and/or deployed in North Ameri ...
-
Senior Electrical Engineer
1 week ago
Kearfott Raleigh, United StatesTracking Code · Job Description · Kearfott Corporation, a global avionics motion control and navigation supplier, is a leader in the design and manufacture of precision motion control products and inertial control components. Our inertial guidance and navigation systems control ...
-
Director of Manufacturing
3 days ago
Targan, Inc. Raleigh, United StatesThis role is responsible for the application of technology and operational excellence in all manufacturing processes for both new product introduction and in support of existing products that are produced and/or deployed in North America. The role will work closely with a cross f ...
-
Electrical Engineer, R&D
1 week ago
Hitachi Raleigh, United StatesLocation: · (HE)Office_NC, Raleigh 901 · Job ID: · R · Date Posted: · Company Name: · HITACHI ENERGY USA INC · Profession (Job Category): · Engineering & Science · Job Schedule: · Full time · Remote: · No · Job Description: · At Hitachi Energy our purpose is advanc ...
-
Electrical Engineer, R&D
5 days ago
Hitachi Raleigh, United StatesLocation: · (HE)Office_NC, Raleigh 901 · Job ID: · R · Date Posted: · Company Name: · HITACHI ENERGY USA INC · Profession (Job Category): · Engineering & Science · Job Schedule: · Full time · Remote: · No · Job Description: · At Hitachi Energy our purpose is advancing a su ...
Principal Engineer NPI - Raleigh, United States - Merz North America
Description
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
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR c)
