Principal Engineer - Process & Tooling

Principal Engineer
- Process / Tooling For NPI

Founded in 1908, Merz is a successful, family-owned specialty healthcare company with a rich history. As a leading global aesthetics business, our award-winning portfolio of injectables, devices, and skincare products empowers healthcare professionals to enhance confidence through aesthetic medicine. Our purpose is to fuel confidence by helping people look better, feel better, and live better. We believe you do not have to choose between living life and making a living.

Live your best life with Merz Aesthetics.

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.

• Process Development and Validation: 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.
• Equipment & Automation: Specify manufacturing equipment and equipment requirements, commissioning, and qualification. Support automation and semi-automation initiatives to improve efficiency and repeatability.
• Prototype Manufacturing: Lead engineering prototype builds, including generating BOMs, ordering parts and materials, creating incoming inspection standards and train lab technicians as necessary.
• Subject Matter Expert: Provide technical expertise to cross functional groups including operations, quality, regulatory, and clinical, especially in technical explanation and root cause analysis
• 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.
• Documentation: Create and maintain accurate documentation throughout the design and development process per GDP and GMP
• Test Methods: Involved is writing test method plans, procedures, work instructions, rationales, memos, and data analysis as it relates to technical requirements and specifications.

• 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

• 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, 21
  
  CFR
  1050.10, MIL-STD-1376), ISO
  13485, 21 CFR 820:30

• 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.)
• Familiarity with electrical or electronic characterization such as:(impedance, acoustic tank, pulse-echo, force balance, transmitting voltage response) ultrasound devices
• 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
• Common use of Solid Works, Finite Element Analysis (FEA), Statistics or DOE techniques
• 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 Power Point