Manufacturing Engineer II

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 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 serves 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 thats redefining medical device manufacturing. If youre passionate about innovation and thrive in a fast-paced environment wed love to hear from you.

• 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.

• Minimum of 3 years of experience in an engineering role within a manufacturing environment preferably supporting New Product Introduction or process transfer activities.
• Bachelors 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.

• 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.

• The compensation for this role is competitive and will be based on experience and qualifications. The anticipated range is $65000$102000.

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