Careers

• Actively support NPI by working hands-on on the production floor to troubleshoot issues, stabilize yields, and drive smooth transitions from development to full-scale manufacturing.
• Collaborate with Development and R&D Engineers to execute effective design transfer, process characterization, and ramp plans.
• Conduct process capability studies and apply DOE, SPC, and data-driven analysis to draw conclusions, implement improvements, and sustain gains.
• Develop standard work, process controls, and monitoring methods to reduce variability across operators, materials, equipment, and workflows.
• Investigate process deviations and failures; perform structured root cause analysis (5-Why, Fishbone, FMEA) and implement robust corrective and preventive actions (CAPA).
• Proactively identify opportunities for improvement and challenge assumptions constructively to drive better outcomes.
• Create and execute IQ/OQ/PQ and related verification and validation protocols, analyze results, and generate complete documentation and reports.
• Ensure compliance with design control, validation, documentation, and change-control policies (FDA, ISO, cGMP, QMS).
• Create and maintain clear, complete manufacturing documentation (MPIs, LHRs, WIs, forms, checklists) that reflect current practices and controls.
• Train and guide technicians and assemblers; drive best practices and foster a culture of safety, quality, and continuous improvement.
• Contribute to design-for-manufacturability (DFM), cost reduction, quality improvement, and automation initiatives.
• Cultivate a mindset of ownership and innovation, where individuals actively seek out challenges and collaborate across teams to solve them

• 3–7 years of hands-on experience in a manufacturing environment, with a proven track record in process development, optimization, and validation.
• Extensive experience with process capability studies, FMEA, PPK, GR&R, SPC, and process development/validation.
• Knowledge and experience with plastic injection molding as well as semi-automated and fully automated machines/processes
• Proven ability to perform statistical data analysis and implement improvement plans using DOE and other methods.
• Strong analytical and problem-solving skills including but not limited to DOE, and statistical data analysis
• Knowledge of material science and polymer chemistry
• Diverse background in process characterization and optimization in a manufacturing environment.
• Experience with FDA regulations and ISO, cGMP, and QMS standards.
• Experience with Statistical Software tools such as Minitab or JMP
• Familiarity with cleaning and sterilization processes
• Working knowledge of SolidWorks

• Bachelor’s Degree in Mechanical, Chemical, Manufacturing, or a related engineering field.
• Relevant certifications as pertains to the position (e.g., Six Sigma, Lean Manufacturing, etc.) is a plus.
• Proficiency in Microsoft Excel, Microsoft Word, and other engineering software tools.
• Familiarity with metrology tools such as CMM, Micro-Vu, SEM, etc. is a plus.

• The employee is regularly required to stand, walk, and sit for extended periods during the performance of job duties.
• Must be able to physically be present on-site to perform the required tasks.

Pay Range: $137,000 – $160,000 per year

• Lead the design, implementation, and continuous improvement of complex manufacturing processes, ensuring scalability, reliability, and cost-effectiveness.
• Revamp entire manufacturing workflows to enhance productivity, quality, and compliance while reducing cost and labor.
• Conduct advanced process capability studies and Design of Experiments (DOEs); utilize statistical analysis software (Minitab, JMP) to interpret results and propose actionable improvements.
• Develop new process policies, procedures, and standards that improve cross-departmental efficiency and regulatory robustness.
• Mentor and guide junior engineers by reviewing work, providing feedback, and delegating subprojects within larger manufacturing initiatives.
• Contributes to and influences strategic decisions impacting manufacturing and product delivery.
• Design and execute process validation protocols (IQ, OQ, PQ) at manufacturing scale; collaborate with Quality and Validation departments to meet business demands.
• Troubleshoot complex manufacturing issues through root cause analysis, coordinating with multidisciplinary teams to implement sustainable corrective actions.
• Drive cross-functional initiatives to ensure manufacturing processes align with R&D, Quality, and Supply Chain objectives.
• Analyze high-complexity data sets to monitor process performance, identify improvement areas, and optimize throughput and yield.
• Develop and maintain comprehensive manufacturing documentation, including MPIs, LHRs, and WIs, ensuring consistency and compliance with QMS standards.
• Represent Manufacturing Engineering in strategic discussions, providing technical recommendations that influence broader business and operational decisions.
• Promotes open exchange of ideas, feedback, and collaboration across departments and teams.
• Serves as a representative of the company, demonstrating accountability and acting in its best interest.

• Bachelor’s Degree in Mechanical, Chemical, Manufacturing or related engineering fields
• 6-8 years hands-on experience in a manufacturing environment with proven track record of process development /optimization and validation
• Excellent verbal, written, presentation and interpersonal skills
• Prior experience with FDA regulations and ISO, cGMP, QMS standards, etc.
• Creative, self-motivated, flexible to work in a small company environment and assume a wide variety of tasks
• Strong analytical and problem-solving skills including but not limited to DOE, and statistical data analysis
• Extensive experience with process capability studies, FMEA, PPK, GR&R, SPC and process development/validation
• Knowledge and experience with plastic injection molding as well as semi-automated and fully automated machines /processes
• Knowledge of material science and polymer chemistry
• Diverse background in process characterization and optimization in a manufacturing environment.
• Hands-on proactive approach to problem solving
• Requires interaction and collaboration with a cross-functional team

• Experience with Statistical Software tools such as Minitab or JMP
• Knowledge and/or hands-on experience with metrology tools such as CMM, Micro-Vu, SEM, etc.
• Familiarity with cleaning and sterilization processes
• Working knowledge of SolidWorks

Pay Range: $155,000 – $180,000 per year

• Interpret drawings and specification documents.
• Perform incoming inspection of materials/components/subassemblies/finished products following standard operating procedures and using standard inspection tools, including the MicroVu and Keyence.
• Determine inspection sample size based on procedures, specifications, and standards.
• Help develop inspection methods, including automated inspection programs using the MicroVu and Keyence.
• Review/approve executed batch records for manufacturing and inspection records in accordance to QMS procedures and Good Documentation Practices.
• Approve/perform final disposition of materials/components/subassemblies/finished products.
• Assign and apply expiration dating labels to materials/parts/products, as per specifications/quality procedures.
• Initiate Non-Conformance Material Reports (NCMRs) and deviations when discrepancies are observed during inspections and record review process. Report discrepancies and issues to QA Engineering and affected function(s).
• Maintain materials in Quarantine (pending disposition) and MRB (under NCMR and deviations) in order.
• Maintain accurate records as per Document Control procedures.
• Support training of IQC personnel.
• Assist with performing environmental monitoring of Controlled Environment Rooms (CERs), as needed.
• Support Quality in the collection of quality metrics data.
• Interact closely with different functions of the organization.

• 2-5 years of experience performing inspections and reviews/approvals of manufacturing batch records/inspection records
• Government Regulated Environment experience such as FDA and ISO 13485
• Must have adequate computer experience (knowledge of Microsoft Word, Excel)
• Experience working in a cGMP environment

• Attention to detail and organizational skills
• Good interpersonal and communication skills
• Ability to work as a part of a team and promote a team environment

Pay Range: $130,000 – $160,000 per year

• Interpret drawings and specification documents.
• Perform incoming inspection of materials/components/subassemblies/finished products following standard operating procedures and using standard inspection tools, including the MicroVu and Keyence.
• Determine inspection sample size based on procedures, specifications, and standards.
• Help develop inspection methods, including automated inspection programs using the MicroVu and Keyence.
• Review/approve executed batch records for manufacturing and inspection records in accordance to QMS procedures and Good Documentation Practices.
• Approve/perform final disposition of materials/components/subassemblies/finished products.
• Assign and apply expiration dating labels to materials/parts/products, as per the specifications/quality procedures.
• Initiate Non-Conformance Material Reports (NCMRs) and deviations when discrepancies are observed during inspections and record review process. Report discrepancies and issues to QA Engineering and affected function(s). Work with NCMR and deviation owners to ensure action plans are completed in a timely manner.
• Maintain materials in Quarantine (pending disposition) and MRB (under NCMR and deviations) in order.
• Maintain accurate records as per Document Control procedures.
• Coordinate IQC priorities and monitor IQC tasks and deliverables.
• Support training of IQC personnel.
• Handling and shipping of samples to external testing laboratories.
• Assist in the coordination of equipment preventative maintenance and calibration and maintaining equipment files.
• Assist with performing environmental monitoring of Controlled Environment Rooms (CERs).
• Review and update Standard Operating Procedures (SOPs) to ensure compliance with the QMS.
• Support Quality in the collection of quality metrics data and data monitoring.
• Assist QA during quality audits.
• Interact closely with different functions of the organization.
• Performs other duties as needed to support the Quality Assurance Department and the company.

• Minimum of 5-6 years of related work experience, especially performing inspections and reviews/approvals of manufacturing batch records/inspection records.
• Government Regulated Environment experience such as FDA and ISO 13485
• Must have adequate computer experience (knowledge of Microsoft Word, Excel)
• Experience working in a cGMP environment

• Attention to detail and organizational skills
• Good interpersonal and communication skills
• Ability to work as a part of a team and promote a team environment

Pay Range: $45 – $52 per hour

• This individual will be responsible for supporting the Product Lifecycle, Design Control, and Design Transfer processes, as well as the quality elements of design projects
• Provide quality assurance oversight and ensure compliance in the support of combination device development life cycles
• Ensure product development projects and changes to existing products are conducted in compliance with the Quality System Regulations
• Lead risk management activities and participate in cross-functional teams to develop and maintain Product Risk Management Files (Risk Management Plan & Report, HA, UFMEA, DFMEA, PFMEA, etc.)
• Lead test method validation activities and Gage R&R studies for Combination Product
• Oversee calibration and preventive maintenance program
• Apply knowledge of Design Control principles and quality engineering to positively influence new product development efforts, including establishing, reviewing, and approving design inputs/outputs, Design Verification & Validation, Process Characterization & Validation, Component Qualification
• Identify quality characteristics and validation criteria for components, subassemblies, and finished product
• Work with R&D in the creation of requirements for new products and engineering specifications
• Responsible for assuring design projects meet quality goals, and regulatory requirements including FDA Quality System Regulations, ISO 13485, EU MDR requirements, and Risk Management per ISO 14971
• Provides direction to Engineering to establish, implement, and maintain policies and procedures designed to ensure compliance with all necessary and appropriate quality standards within the area of Design Controls
• Serve as a technical resource for assessing validation requirements, solving test related problems, and developing preventive strategies
• Assist in the development and approval of design development plans, verification and validation protocols, reports, master V&V plans and reports
• Support quality assurance activities, including, but not limited to: internal and external audits, NCMRs and CAPAs,
• Assist in development, review and approval of process and equipment validation/qualifications (IQ, OQ, PQ)
• Other duties/ activities may be necessary to support departmental or company goals

• A minimum of 8 years quality assurance/engineering in a regulated industry (medical device,) is required
• BS degree in Mechanical Engineering or related field is required
• Demonstrated competency with Medical Devices Design Controls, 21 CFR 820, MDR, ISO 13485
• Experience with Risk Management process (Risk Management Plan/Report, FMEA’s) and associated standards (ISO 14971:2019)
• Understanding of multiple technological areas (software, mechanical, electrical, biomedical, test automation, etc.)
• Must be a self-starter and capable of working independently and within a team.
• Experience performing statistical analysis (Six Sigma preferred)
• CQE, CQA preferred

• Ability to motivate and influence people
• Must possess the ability to handle multiple tasks with high attention to detail Organizing, planning, and problem-solving skills
• Good interpersonal and communication skills
• Ability to work as a part of a team
• Ability to review, analyze, summarize, and interpret data; draw conclusions and make appropriate recommendations and decisions; write reports
• Ability to create and provide training
• Good statistical and numerical ability
• Exceptional problem-solving skills

Understands and can subsequently explain complex quality details to non-expertsPay Range: $150,000 – $190,000 per year

• Maintain and improve the quality system in accordance with FDA Quality System Regulation and ISO 13485 requirements
• Support quality assurance activities, including, but not limited to: Risk Management (FMEAs, HA), internal and external audits, NCMRs and CAPAs
• Investigate product quality problems and determine root cause, gather and analyze data, and implement corrective actions to reduce or eliminate cause
• Manage the Non-conforming Materials Review (NCMR) in collaboration with Operations to ensure timely reporting, analysis, and resolution of non-conforming material
• Lead the resolution of quality issues related to non-conformance reports and CAPAs
• Support Operations team in the maintenance and continuous improvement of product and manufacturing processes
• Assist in development, review and approval of process and equipment validation/qualifications (IQ, OQ, PQ).
• Provide QE support to production, purchasing and engineering
• Support/lead test method validation activities
• Conduct and support the development and validation of appropriate test methods for product and process performance
• Develop and initiate sampling procedures and statistical process control methods
• Support product line manufacturing and design stages by ensuring validation of manufacturing equipment and processes are conducted in accordance with the Validation Master Plan
• Address systemic quality issues with suppliers or internal groups
• Assist in the review of lot history records and disposition of product (subassembly and finished goods)
• Work with process and R&D engineers to develop adequate inspection criteria
• Perform statistical analysis such as capability, gage R&R, and statistical process control
• Evaluate product changes for qualification and validation requirements and assist in change implementations
• Other duties/ activities may be necessary to support departmental or company goal

• A minimum of 6 years quality assurance/engineering experience is required. Experience in a regulated industry (medical device,) is required
• BS degree in Engineering is required
• Experience with FDA Quality System Regulations and ISO Standards (ISO 13485 and ISO 14971) is required
• Experience with non-conformances, CAPA, and Risk Management is required
• Experience in performing test method validation and Gage R&Rs
• Extensive experience regarding root cause analysis and statistical techniques (such as Cause and Effect Analysis, Fishbone Diagram, 5 Whys, Six Sigma processes)
• CQE, CQA preferred

• Ability to motivate and influence people
• Must possess the ability to handle multiple tasks with high attention to detail Organizing, planning, and problem-solving skills
• Good interpersonal and communication skills
• Ability to work as a part of a team
• Ability to review, analyze, summarize, and interpret data; draw conclusions and make appropriate recommendations and decisions; write reports
• Ability to create and provide training
• Good statistical and numerical ability
• Exceptional problem-solving skills
• Understands and can subsequently explain complex quality details to non-experts

Pay Range: $130,000 – $160,000 per year