Principal Engineer - Process & Tooling

Merz North America•Raleigh, NC

About The Position

The Principal Engineer - Process / Tooling for NPI is a hands-on technical leader and SME in manufacturing processes, tooling, automation, material processing, equipment qualification, and process optimization. This position requires the ability to develop manufacturing strategies, solve technical challenges, implement innovative process solutions, and deliver scalable, repeatable production systems through design transfer. The position leads both internal development activities and external partners, including suppliers and CMOs, overseeing tooling, molds, automation, materials, manufacturing readiness, and build execution. The ideal candidate is a self-driven problem solver, technical leader, and influencer who can manage multiple complex projects while collaborating across cross-functional teams.

Requirements

Bachelor of Engineering (B.E.) in ME or EE or other relevant Engineering discipline
7-10 years of related development experience in the medical device and/or electronics industry
5+ years of experience within R&D product development creating devices and/or adding product features that were successfully released
2+ years of experience mentoring and supervising other engineers and technicians
Knowledge of design for manufacturing (DFM), from feasibility through transfer to production
Capable to lead multiple NPI projects simultaneously, ability to build relationships, Influence cross-functional teams without direct authority, and successfully launch and transfer new products
Skills in managing and coordinating tooling, tooling budgets, capital expenditures and R&D build schedules while coordinating internal teams and external manufacturing partners
Subject matter expertise in at least one engineering discipline (e.g. EE, SW, Materials, Manufacturing Process’, Tooling/Automation, Mechanical, Ultrasound, etc.)
Strong familiarity with medical device product development process and proven capability strategizing and leading verification / validation efforts for FDA submission info and design transfer completion
Ability to develop RFP, RFQ, and SOW for internal functional groups or outside vendors
Design and development of new products, features which require orchestration of deliverables from multiple functional groups
Effective interpersonal skills enabling constructive communication with cross functional groups
Must be proficient in MS Word, Excel, and PowerPoint

Nice To Haves

Master's Degree MBA / Master’s in ME or EE or other relevant Engineering discipline
Medical Device Product Development Process
Good Manufacturing Practices
Familiarity with acoustic standards (IEC 60601-2-62, IEC 60601-2-37, 21CFR1050.10, MIL-STD-1376), ISO13485, 21 CFR 820:30
Familiarity with electrical or electronic characterization such as:(impedance, acoustic tank, pulse-echo, force balance, transmitting voltage response) ultrasound devices
Common use of SolidWorks, Finite Element Analysis (FEA), Statistics or DOE techniques

Responsibilities

Develop robust manufacturing process’ using risk-based methods. Create and execute: Installation (IQ), Operational (OQ), Performance (PQ) Qualifications including Process Validation Plans, Protocols and Reports.
Perform process characterization, capability studies, and DOE activities to establish process control and acceptance criteria.
Design, build, and test products per 21CFR820 using design for manufacturing (DOE) approach to mitigate risk and improve designs.
Leading simulations and/or fabrication testing of various product iterations, as well as develop and create product requirements, test plans/protocols and managing their planning and execution.
Specify manufacturing equipment and equipment requirements, commissioning, and qualification. Support automation and semi-automation initiatives to improve efficiency and repeatability.
Coordinate equipment integration with production systems, CMO’s and sustaining engineering colleagues.
Lead engineering prototype builds, including generating BOMs, ordering parts and materials, creating incoming inspection standards and train lab technicians as necessary.
Work closely with product development teams, suppliers and R&D engineers to pilot new manufacture product development and assembly methods.
Provide technical expertise to cross functional groups including operations, quality, regulatory, and clinical, especially in technical explanation and root cause analysis
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 mitigation, review and discuss tooling issues while developing multiple contingency plans throughout development process.
Create and maintain accurate documentation throughout the design and development process per GDP and GMP
Involved is writing test method 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 tooling and setup.