We are seeking a highly experienced and technically skilled Principal Quality Engineer to lead critical quality engineering activities for Drug Delivery, IVD and Medtech platform projects.
Responsibilities
Serve as the technical quality lead for Drug Delivery, IVD and Medtech platform projects, providing strategic direction and deep expertise across all phases of product development, from concept through commercialization.
Act as the primary quality engineering authority on complex, multi-component assembly projects involving multiple injection molded components, ensuring robust design transfer, validation, and scalability.
Provide quality oversight, supplier controls and technical leadership in managing external consultants, design partners, and contract development/manufacturing organizations (CDMOs), ensuring alignment with internal quality standards, regulatory requirements, and project timelines.
Drive the development and execution of process validation strategies (IQ/OQ/PQ) for molded and assembled components.
Collaborate cross-functionally to develop and maintain key process control elements including pFMEAs, Control Plans, acceptance criteria, and inspection documentation tailored to high-precision, regulated products.
Lead and manage the Malden manufacturing operation, ensuring safety, quality, cost performance, throughput, and associate development.
Responsibilities
Lead the Malden manufacturing operation with accountability for safety, quality, service, cost, throughput, schedule attainment, sanitation, labor effectiveness, and overall plant performance.
Establish clear operational standards, performance goals, equipment expectations, and operating cost objectives aligned with the annual plan.
Drive reliable production output and efficient growth by ensuring the right equipment, staffing, operating systems, and performance measures are in place.
Lead regular operating reviews with plant leadership to evaluate productivity, downtime, quality, staffing, schedule attainment, and corrective actions.
Ensure manufacturing systems, procedures, and policies are consistently deployed, understood, and followed across assigned operations.
Requirements
Bachelor’s degree in Engineering, Technology, Business, Operations Management, or a related field
Nice to have: popcorn or corn or grain or ingredient or food processing experience
Serve as the technical anchor bridging Product Development and Operations, leading the transition of innovative medical devices from R&D through design transfer, driving Design for Manufacturability (DFM), pilot line validation, and robust process development.
Responsibilities
Serve as the primary manufacturing technical lead on New Product Introduction (NPI) core teams, partnering early with R&D to drive Design for Manufacturability (DFM), Design for Assembly (DFA), and seamless design transfer into commercial production.
Architect, establish, and optimize robust manufacturing processes and standardized Control Plans, ensuring critical-to-quality (CTQ) parameters are controlled, and processes meet target capability prior to commercialization.
Lead the conceptualization, CAD design, and qualification of custom jigs, fixtures, and tooling across assembly cells, sterilization, QA inspection, and final packaging to maximize yield and operator ergonomics.
Author, execute, and approve complex equipment and process validation protocols (IQ/OQ/PQ, Test Method Validation) in strict compliance with ISO 13485 regulatory requirements.
Plan and execute complex engineering studies, Design of Experiments (DOE), and root cause analyses (RCA) to characterize process windows, resolve technical bottlenecks, and drive data-backed decisions.
Requirements
Bachelor’s degree in Mechanical, Manufacturing, Biomedical, or Materials Science Engineering (or related technical discipline)
The QA Technician is responsible for ensuring that products meet the required quality standards throughout the production process. This role involves testing, inspecting, and auditing products and processes to ensure they comply with regulatory standards, customer requirements, and industry best practices. They are responsible for ensuring compliance with documentation and record-keeping standards, as well as reporting the outcomes of quality initiatives.
Compensation
Earn a $500 bonus for maintaining a full-time status for the first 90 days of employment with good attendance.
Responsibilities
Follow established safety procedures to maintain a safe working environment
Foster awareness of quality standards and objectives
Support the interpretation of work orders and technical drawings
Lead supplier development initiatives focused on manufacturing capability, capacity, scalability, and operational readiness to support current and future business needs.
Locations (6)
Beachwood, Ohio, United States
Charlotte, North Carolina, United States
Jackson, Michigan, United States
Menomonee Falls, Wisconsin, United States
Moon Township, Pennsylvania, United States
Principal Production Engineer Energetics Manufacturing - 2nd Shift
Provide hands‑on engineering support for energetic materials production and related assemblies during second‑shift operations, ensuring safe, efficient, and reliable manufacturing.
Provide technical support during production events, troubleshoot issues on second shift, and coordinate follow‑up actions with day shift and supporting engineering organizations.
Develop, maintain, and improve process‑control documentation, standard work, operating procedures, work instructions, work measurement standards, and tooling‑use documentation.
Support the planning, design, launch, and improvement of manufacturing lines for new products and product upgrades, including facility, utility, equipment, tooling, and fixture requirements.
Assist with development and implementation of tooling components for energetic aerospace propulsion systems including molds, lifting devices, handling fixtures, test fixtures, and other production‑support equipment.
Support tool use, checkout, maintenance, and follow‑up in production; identify opportunities to improve existing tooling and production‑support designs.
Provides technical assistance to engineering to support manufacturing efforts by implementing corrective and preventive actions. Assists engineers in developing methods and procedures to control or improve manufacturing processes.
Compensation
Minimum Salary: $ 43368
Maximum Salary: $ 73736
Responsibilities
Assists engineering in providing manufacturing support by learning to analyze data and identify manufacturing issues and trends
Assists in identifying Manufacturing issues by working with Engineering to determine root cause and implement corrective and preventative action
Learns process to disposition non-conforming material by utilizing quality tools and by developing knowledge of manufacturing practices and procedures
Helps to develop and implement process improvements by assisting Engineering in researching and validating changes in processes/equipment and test methods to improve yield and/or reduce cycle time per established procedures
Assists Engineering in supporting process development during new product introduction by providing input to traceability and inspection requirements, providing input for statistical process control criteria, developing manufacturing instructions, and creating training sheets and certifications
Requirements
High School Diploma or equivalent experience, training, or apprenticeships
Provides technical assistance to engineering to support manufacturing efforts by implementing corrective and preventive actions. Assists engineers in developing methods and procedures to control or improve manufacturing processes.
Compensation
Minimum Salary: $ 43368
Maximum Salary: $ 73736
Responsibilities
Assists engineering in providing manufacturing support by learning to analyze data and identify manufacturing issues and trends
Assists in identifying Manufacturing issues by working with Engineering to determine root cause and implement corrective and preventative action
Learns process to disposition non-conforming material by utilizing quality tools and by developing knowledge of manufacturing practices and procedures
Helps to develop and implement process improvements by assisting Engineering in researching and validating changes in processes/equipment and test methods to improve yield and/or reduce cycle time per established procedures
Assists Engineering in supporting process development during new product introduction by providing input to traceability and inspection requirements, providing input for statistical process control criteria, developing manufacturing instructions, and creating training sheets and certifications
Requirements
High School Diploma and/or equivalent experience, training, or apprenticeships
The expected annual salary range for this role is $113000 - $165000 a year.
Responsibilities
Lead structured supplier development activities to identify and close manufacturing, process, capacity, and operational capability gaps
Assess supplier manufacturing processes and drive improvement using process capability analysis, Lean methodologies, structured problem solving
Assess supplier capability and manufacturing controls for precision machining processes
Assess supplier production-rate readiness and capacity against current and future business requirements
Proactively assess and develop supplier readiness to support business growth, new product introductions, supplier transfers, localization, volume increases, and capacity expansions
Requirements
Bachelor’s degree in Engineering, Manufacturing, Quality, Supply Chain, or related technical discipline
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