Current Openings

Developing, writing, reviewing, maintaining and revising manufacturing documentation, i.e. Process Work Instructions, Manufacturing Specifications, Inspection Procedures to support product Manufacturing .Supporting the development and execution of manufacturing equipment qualifications (URS/FAT/SAT/IQ) .Supporting the development and execution of process validations (OQ/PQ/PV).Developing, writing, and reviewing various validation deliverables, i.e. CSV-E, Engineering Studies, etc.Assessing, developing, writing, executing, and reviewing Test Method Validations (TMVs’).Developing, writing, reviewing, and updating relevant Process RisK Documentation (pRAS, pFMEA, FMCA).Partnering with cross functional partners to ensure sound validation strategy and smooth transitions to production go-live.Ensuring adequate documentation where necessary within the Quality System.Participate as an integral member of cross-functional product teams by contributing ideas as well as designing, managing or executing, and interpreting device development activities.Provide engineering support to evaluate, mitigate, re-certify and maintain compliance of the group’s products with new global regulations.Collaborate with cross functions within and outside the group to develop and execute mitigation projects.Manages routine small projects without assistance.Coordinate day-to-day operations of engineering and technical staff assigned to projects by assigning, monitoring and reviewing progress and accuracy of work, directing efforts, and providing technical guidance.The qualifications for this assignment require a minimum Bachelor in Mechanical Engineering or equivalent or any other related degree

Work Location: Raynham, Massachusetts 02767

Salary: $50.00/hr

To apply to the position, send your resume to: hr@fusionlifesolutions.com

Core Competencies & Execution,Autonomous Leadership: Acts as a self-starter with minimal supervision, driving validation workstreams independently while maintaining frequent synchronization with immediate supervisors.Cross-Functional Collaboration: Builds high-trust, collaborative relationships with R&D scientists, manufacturing teams, and quality assurance personnel to achieve agile team goals in a fast-paced biotech setting.Technical Execution & Compliance.Lifecycle Management: Maintains equipment systems in a qualified state by strictly adhering to Denali’s policies, SOPs, and change management procedures.Protocol Development: Authors and executes comprehensive qualification protocols (IQ/OQ/PQ) and summary reports for diverse assets, including analytical instruments, manufacturing skids, and facility utilities.Thermal Validation: Performs rigorous temperature mapping of Controlled Temperature Units (CTUs)—such as freezers, incubators, and stability chambers—utilizing wired or wireless mapping systems (e.g., Kaye Validator, Kaye ValProbes, Ellab).Vendor Management: Supervises OEM vendors and third-party contractors during site acceptance testing (SAT) and qualification activities to ensure deliverables meet internal quality standards.Capital Project Support: Manages projects of defined scope, assisting with equipment implementation from scheduling and procurement through site preparation, installation, qualification, and final turnover to the business owner.Data Integrity: Ensures all qualification and validation documentation is generated with 100% accuracy, completeness, and compliance with Good Documentation Practices (GDP) and Denali’s quality standards.The qualifications for this assignment require a minimum Bachelor of Mechanical Engineering or equivalent or any other related degree

Work Location: Salt Lake City, Utah 84116

Salary: $47.60/hr

To apply to the position, send your resume to: hr@fusionlifesolutions.com

Drafting and assessing Failure Mode Effects and Analysis (FMEA), Criticality Assessments (CA), Control Plans (CP), CTQs, KPI, Validations and Verifications conventions.Create Non-confonnance reports (NCRs) and Corrective Actions/Preventive Actions to resolve quality issues.Validated the process on thermoforming equipment. Ensured compliance with quality approaches, methods, and practices for clinical developments.Directed IQ/OQ/PQ as well as other comparative capability and regulate check and approval of new plans or changed procedures, get together and test installations.Structure audits, support for the DHF, and audits of documentation and Technical Files are all supported by supported item dispatch and stage survey forms.A solid comprehension of the thermoforming or vacuum forming procedure. Knowledge of geometric tolerances and dimensions (GD&T), as required by blueprints. Performed Process Validation exercises and procedure observing on Plastic Injection molding Equipment's and packaging equipments. Worked on test technique approvals (TMV) for materials meets the real parts and item and Master Validation Plans (MVP) for the procedure. Adherence to current Good Manufacturing Practices (GMP) and Statistical Process Control (SPC) through the creation and implementation of appropriate supporting documentation, SOPs, and process work guidelines (WI). Look into and find solutions to everyday problems related to manufacturing engineering. Being a part of core teams, creating new procedures, researching best practices, involving shop personnel, conducting cost analyses and justifications, drawing layouts, and obtaining approvals are all examples of these tasks. Utilizing FMEA and other risk, identify, analyze, and manage risk throughout the product life cycle. Working with operations to meet supply and demand by continuously improving the processes and optimizing the performance metrics.Revision and implementation of the Quality Management System to guarantee confidence and uniformity. Created and put into action procedures and operation sequences for the production and fabrication of parts, components, sub-assemblies, and final assemblies. Participated in the design of fixtures and the writing of new test method instructions for new test methods.Developed Non-conformance reports and carried out corrective and preventative measures. The qualifications for this assignment require a minimum Bachelor in Mechanical Engineering or equivalent or any other related degree

Work Location: Gainesville, Florida 32607

Salary: $45.00/hr

To apply to the position, send your resume to: hr@fusionlifesolutions.com

Support FDA 483 remediation activities within manufacturing operations, with a focus on capital and electromechanical products.Perform detailed process risk analysis, reviewing and scrubbing PFMEAs to ensure all process steps, failure modes, and mitigations are accurately identified and implemented Evaluate manufacturing processes end-to-end, confirming that identified mitigations are appropriate, effective, and reflected in procedures and work instructions.Assess validation status across manufacturing processes, including IQ/OQ/PQ and Test Method Validation (TMV), ensuring downstream verification strategies are accurate and defensible.Review and update manufacturing documentation, including procedures, work instructions, and DHF elements, to ensure alignment between documented processes and actual production practices.Partner closely with Manufacturing, Quality, and Engineering teams to close gaps, implement corrective actions, and drive sustainable remediation outcomes.Support manufacturing areas involving dimensional inspection, detection systems, and capital equipment, then expand remediation support across additional processes as needed.The qualifications for this assignment require a minimum Bachelor of Mechanical Engineering or equivalent or any other related degree

Work Location: Newark, DE 19702.

Salary: $51.00/hr

To apply to the position, send your resume to: hr@fusionlifesolutions.com

Conduct comprehensive Process Failure Mode and Effects Analysis (PFMEA) assessments, including identification of potential failure modes, evaluation of risk priority, and implementation of mitigation strategies to ensure robust manufacturing processes.Perform risk analysis and gap assessments on existing manufacturing processes, work instructions, and standard operating procedures (SOPs), and lead remediation efforts to align with regulatory and quality standards. Develop, execute, and document process validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), ensuring compliance with FDA and industry standards. Design and perform Test Method Validation (TMV) activities, including statistical analysis such as Gage Repeatability and Reproducibility (Gage R&R), to ensure accuracy and reliability of inspection and testing methods. Lead root cause investigations using structured problem-solving methodologies (e.g., Fishbone Analysis, 5 Whys) and implement effective corrective and preventive actions (CAPA). Apply Design of Experiments (DOE) and statistical tools to optimize manufacturing processes and improve product quality, efficiency, and yield.Support continuous improvement initiatives by analyzing production data, identifying trends, and implementing process enhancements in alignment with Lean and Six Sigma methodologies. Manage non-conformance reports (NCMR), deviations, and change controls, ensuring proper risk linkage, documentation, and regulatory compliance.Collaborate cross-functionally with manufacturing, quality assurance, and program management teams to support process development, technology transfer, and production sustainment..The qualifications for this assignment require a minimum Bachelor of Mechanical Engineering or equivalent or any other related degree

Work Location: Newark, DE 19702.

Salary: $45.60.00/hr

To apply to the position, send your resume to: hr@fusionlifesolutions.com

Expertise in test method validation, ability to create and develop test methods, making sure the test method at the supplier and client are aligned. Write incoming/receiving quality instructions (IIs) while working with suppliers to ensure components meet established standards.Create Instruction Inspection methods to test supplier components at Hologic. Coordinate any effort needed to provide the supplier with fixtures if needed to do inspection testing. Coordinate with R&D and/or MFG Engineering, revising raw material specifications to include missing inspection criteria.Execute and support IQ/OQ/PQ for manufacturing and supplier processes.Assess and qualify suppliers, oversee their manufacturing and quality practices, resolve supplier non-conformances.Lead data-driven improvements using tools like PPAP, SPC, GR&R, and CAPA investigations and root cause analysis.Understanding of PPAP (Production Part Approval Process) concepts and requirements (desirable).Knowledge of validation (IQ, OQ, PQ), risk management, and CAPA processes as they relate to suppliers.Strong grasp of metrology, measurement systems analysis (MSA, including GR&R), and quality records requirements.Experience in Manufacturing Engineering or Quality Engineering within medical devices.Statistical Process Controls (CPK, PPK, SPC Charts).Experience in Manufacturing Engineering or Quality Engineering within medical devices.The qualifications for this assignment require a minimum Bachelor of Mechanical Engineering or equivalent or any other related degree

Work Location: Newark, DE 19702.

Salary: $60.00/hr

To apply to the position, send your resume to: hr@fusionlifesolutions.com

Review and approve design control deliverables in support of orthopedic tray and case programs.Support design transfer activities, ensuring alignment between R&D, suppliers, and manufacturingCompile and review documentation for process verification / process validation activities at suppliersInterface directly with external vendors, including review of data, inspection criteria, and manufacturing processesRead and interpret engineering drawings; develop inspection plans and inspection sheetsSupport incoming inspection and distribution site activities, including documentation review and system transactionsInvestigate supplier-related nonconformances, author investigation reports, and communicate findings and expectations to suppliersSupport steam sterilization–related processes for trays and casesUtilize multiple quality and PLM systems to manage documentation and data (e.g., nonconformances, inspections, reports)Coordinate day-to-day operations of engineering and technical staff assigned to projects by assigning, monitoring and reviewing progress and accuracy of work, directing efforts, and providing technical guidance.The qualifications for this assignment require a minimum Bachelor of Engineering in Mechanical Engineering or equivalent or any other related degree

Work Location:Westchester,Pennsylvania 19380

Salary: $50.00/hr

To apply to the position, send your resume to: hr@fusionlifesolutions.com

Reviewing the quality management system and analyzing quality objectives that are designed to improve manufacturing's bottom line by utilizing the 21CFR 820 guidelines with extensive Knowledge in Quality Assurance/Audits.Reviewing and writing Process Validation (IQ, OQ, PQ), Master Validation Plans, Test Method Validation (Gage R&R), Process FMEA’sEstablishing and validating improvements to systems and processes that support warehouse management systems (SAP/JED), quality management systems, software systems, CAPAs, non-conformances, change control, document management, training, metrics reporting, trending and statistics, calibration, preventive maintenance, and audit processes (internal and external).Development and implementation of cold chain and temperature controlled ambient solutions and validation protocols in distribution and transportation.Participate and lead investigations, remediation activities, standards development and implementation, audits, and training.Identification of preventive opportunities to continuously improve quality, cost, and time factors.Work on individual component drawings 2D in Auto-Cad and 3D in Solid works and revising tolerances as necessary as per Customer Requirements and Internal process Capability Reports.Knowledge in analytical tools like; GR&R. Statistical Process Control; Lean Techniques; Design for Six Sigma; GD&T; Tests of Hypothesis; Analysis of Variance; Measurement System Analysis, Designs of Experiment.Expertise in mitigating FDA 483 Warning Letters and correcting documentation for established medical device manufacturers in the areas of Design History Files, remediation, Risk Analysis, and Design Verification and Validation activities.Expertise in Process Development, Manufacture and Project Management of Class I, II and III medical devices.Proficiency in the body of knowledge which includes but is not limited to: First party (in house) and 2nd Party (Supplier) audits; use of Six Sigma and Risk Management Analysis tools for, Process, Product and Quality Systems.Knowledge of on various Quality Systems: ISO 9000; Medical Device Standards: ISO 13485, Medical Device Directive 93/42 EEC, 21 CFR part 820, part 211 and the Risk Management Standard.In-depth knowledge of the following FDA Regulations: GCP (Good Clinical Practices); GLP (Good Laboratory Practices Non - Clinical Studies); 510(k), PMA, and IDE Regulatory Procedures.

Work Location:Londonderry, New Hampshire, 03053.

Salary: $60.00/hr

To apply to the position, send your resume to: hr@fusionlifesolutions.com

Perform project management activities for a complete project or portions of major projects to deliver validated manufacturing processes, clinical product, regulatory approvals and robust commercial production capabilities.Assist in new and existing product, process and equipment design.Lead and manage design control activities across entire projects.Manage detailed designs including drawings, tolerances & specifications.Prepare oral and written technical and progress reports regarding projects. Preparation of strategies, protocols, data collection, data analysis and presentation, and completion reports.Manage short to medium scale capital projects.Independently performs project activities with general instruction.Create and participate in a work environment in which change is embraced, and collaboration is the foundation of success.Responsible for communicating business related issues or opportunities to next management level.Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.The qualifications for this assignment require a minimum Bachelor in Engineering or equivalent or any other related degree.

Work Location:Plymouth, Minnesota 55442.

Salary: $60.80/hr

To apply to the position, send your resume to: hr@fusionlifesolutions.com

Drafting and assessing Failure Mode Effects and Analysis (FMEA), Criticality Assessments (CA), Control Plans (CP), CTQs, KPI, Validations and Verifications conventions.Responsible for settling quality issues by making Non-confonnance reports (NCRs) and Corrective Actions/Preventive Actions.Performed process validations on thermoforming machinery.Ensured compliances with clinical developments quality approaches, methods, and practices.Directed IQ/OQ/PQ as well as other comparative capability and regulate check and approval of new plans or changed procedures, get together and test installations.Supported item dispatch and stage survey forms - structure audits, support of DHF, and audit of documentation and Technical Files.Good understanding of the process of thermoforming or vacuum forming.Understanding of Geometric dimensions and tolerance (GD&T) as required on blueprints.Performed Process Validation exercises and procedure observing on Plastic Injection molding Equipment's and packaging equipments..Worked on test technique approvals (TMV) for materials meets the real parts and item and Master Validation Plans (MVP) for the procedure.Development and execution of suitable supporting documentation, SOPs, process work guidelines (WI) and agreeable with current Good Manufacturing Practices (GMP) and Statistical Process Control (SPC).Investigate and resolve day-to-day manufacturing engineering related issues.Participating on core teams, designing new processes, researching best practices, involving shop personnel, performing cost analysis/justification, drawing layouts, and obtaining approvals.Identify, analyze, and manage risk through product life cycle with use of FMEA and other risk.Working with operations to meet supply and demand by continuously improving the processes and optimizing the performance metrics.Revision and implementation of Quality Management System to ensure conformity, uniformity, and confidence.Developed and implemented operation sequence and processes in the manufacturing and fabrication of parts, components, sub-assemblies, and final assemblies.Involved in new test method development that entail designing fixtures and writing new test method instructions.The qualifications for this assignment require a minimum Bachelor in Mechanical Engineering or equivalent or any other related degree.

Work Location:Brooklyn Center, Minnesota 55430.

Salary: $48.00/hr

To apply to the position, send your resume to: hr@fusionlifesolutions.com