Manufacturing Engineer II

Resonetics; San Diego (CA); On-site; USD 65,000 - 102,000; Full time

Job summary

Resonetics seeks a Manufacturing Engineer II, NPI to drive the introduction and industrialization of Nitinol-based manufacturing technologies. You will bridge Process Development, Quality, and Production on floor-level implementations and early production ramp-ups.

The role emphasizes hands-on problem solving, process validation (IQ/OQ/PQ), and data-driven improvements to enable robust transfer and scalable manufacturing in a fast-paced life sciences setting.

Qualifications

• Minimum 3 years in engineering within a manufacturing setting, ideally supporting NPI or process transfer.
• Bachelor’s degree in Mechanical or Industrial Engineering or related field.
• Strong ability to generate, maintain process documentation and validation reports.
• Experience in regulated manufacturing environments and quality system requirements.

Responsibilities

• Support transfer of new products and processes from Development to Production with readiness and product integrity.
• Establish Nitinol-based manufacturing processes including laser and inspection operations.
• Execute IQ/OQ/PQ validations and TMVs to ensure robust process validation.
• Develop and maintain WIs, routers, and process documentation for transfer.
• Contribute to initial job cost baselines, cycle times, and ERP standards.

Skills

Technical writing

Regulatory environment knowledge

Lean manufacturing

Data analysis mindset

Education

Bachelor’s degree in Mechanical or Industrial Engineering

Tools

Excel

Power BI

Minitab

CAD / SolidWorks

Job description

Overview

Resonetics is a global leader in advanced engineering, prototyping, product development, and micro manufacturing, driving innovation in the medical device industry. With rapid expansion across all our locations, we continue to push the boundaries of technology while fostering a dynamic, employee-centered culture. Our commitment to excellence and continuous improvement makes Resonetics an exciting place for professionals passionate about shaping the future of micro-manufacturing and being part of something bigger.

We are seeking a Manufacturing Engineer II, NPI to support the introduction and industrialization of new life science manufacturing technologies within our Nitinol processing operations. This role is primarily focused on New Product Introduction (NPI) and the transition of processes from Process Development into Production, while supporting early-phase process characterization, optimization, and stabilization.

The Manufacturing Engineer II, NPIserves as a technical liaison between Process Development, Quality, and Production, ensuring new products and processes are transferred efficiently, validated appropriately, and established with a strong foundation for long-term manufacturing success. This is a hands-on role, requiring active participation on the manufacturing floor to implement improvements, support validations, and train production personnel.

Key Areas of Focus

• Introduction and establishment of Nitinol-based manufacturing technologies such as laser cutting, shape setting, electropolishing, cleaning, and dimensional inspection using CMM and OGP equipment
• Supporting New Product Introductions (NPI) through production readiness, validation execution, and early production ramp-up
• Applying statistical and data-driven methods to characterize processes, establish capability, and support robust process transfer
• Leading assigned NPI and process improvement activities through effective communication, cross-functional coordination, milestone tracking, and regular status reporting

Join Resonetics and be part of a team that’s redefining medical device manufacturing. If you’re passionate about innovation and thrive in a fast-paced environment, we’d love to hear from you.

Responsibilities

• Support the transfer of new products and processes from Process Development into Production, ensuring manufacturing readiness, quality awareness, and product integrity during NPI and early production phases.
• Introduce and establish manufacturing processes for Nitinol-based medical device components, including laser cutting, shape setting, electropolishing, and inspection operations.
• Execute and support process validation activities including IQs, OQs, PQs, and Test Method Validations (TMVs).
• Review, generate, and maintain process documentation including Work Instructions (WIs), routers, and supporting documentation to ensure alignment with process intent.
• Assist in establishing initial job cost baselines, cycle times, and ERP standards for new products and processes.
• Apply structured root cause analysis methodologies, including DMAIC, to investigate NPI issues, early yield losses, dimensional variation, and process instability.
• Utilize statistical tools and techniques such as Design of Experiments (DOE), process capability analysis (Cp, Cpk), ANOVA, regression analysis, and hypothesis testing to identify key drivers of variation and support data-based decisions.
• Support early production process optimization efforts including setup reduction, yield improvement, operator training, and process stability enhancements.
• Provide hands-on technical support during equipment setup, troubleshooting, and qualification activities.
• Collaborate with Quality and Production teams to support resolution of early-phase NCMRs, deviations, and process risks.
• Lead assigned NPI and process-related projects by defining scope, tracking actions and milestones, managing risks, and providing clear, data-driven status updates to stakeholders.
• Serve as a technical point of contact for internal stakeholders and, as needed, customers during NPI and continuation engineering activities.

Required Qualifications

• Minimum of 3 years of experience in an engineering role within a manufacturing environment, preferably supporting New Product Introduction or process transfer activities.
• Bachelor’s degree in Mechanical Engineering, Industrial Engineering, or a related technical discipline, or equivalent hands-on manufacturing experience.
• Strong technical writing skills with the ability to generate and maintain process documentation, validation protocols, and reports.
• Working knowledge of regulated manufacturing environments and quality system requirements.

Preferred Qualifications

• Experience within the medical device industry and familiarity with ISO 13485 and Quality System Regulations (QSR).
• Hands-on experience with Nitinol processing or other precision manufacturing technologies.
• Exposure to laser-based manufacturing processes or similar high-precision equipment.
• Experience applying statistical methods such as DOE, ANOVA, and process capability analysis in a manufacturing environment.
• Familiarity with Lean manufacturing principles and continuous improvement methodologies.
• Experience using data analysis or visualization tools (e.g., Excel, Power BI, Minitab).
• CAD or SolidWorks experience for basic fixture or tooling support.

Compensation

The compensation for this role is competitive and will be based on experience and qualifications. The anticipated range is $65,000-$102,000.

For temp, temp-to-hire, and regular full-time positions, our company policy is that we are unable to provide visa or TN sponsorship. Candidates must already be legally authorized to work in the United States without the need for sponsorship now or in the future.