Current Openings

Develop project plans and schedules, ensuring milestones are met through effective coordination with cross-functional teams. Facilitate cross-functional collaboration among engineering, quality, and operations teams to maintain alignment on project goals and deliverables. Provide leadership and strategic input to product and process development teams, ensuring project outcomes support long-term business and regulatory objectives. Drive automation and technology integration projects, focusing on project timelines, resource allocation, and performance outcomes. Lead and manage the upgrade and modification of existing filling and packaging lines to enhance operational efficiency, throughput, and regulatory compliance. Oversee layout optimization initiatives to improve workflow, ergonomics, and space utilization while aligning with strategic manufacturing objectives. Conduct capacity and feasibility assessments, analyzing production capabilities to support data-driven decision-making and identify improvement opportunities. Manage documentation and deliverables, including creation and approval of User Requirement Specifications (URSs), and ensure alignment with validation activities (IQ, OQ, PQ).Coordinate Factory Acceptance Tests (FATs) and ensure all equipment and systems meet design, performance, and compliance expectations prior to site integration. Supervise the design and implementation of fixturing and tooling solutions, ensuring alignment with automation goals and production efficiency. The qualifications for this assignment require a minimum Bachelor in Engineering or equivalent or any other related degree

Work Location: Middletown, Virginia 22645

Salary: $50.00/hr

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

Updating design requirements affected by the material change. Running design verification (DV) testing to confirm the new cathode material meets specs.Developing/reviewing verification protocols – sample sizes, test matrices, traceability, acceptance criteria. Analyzing test results and authoring verification reports to support the DHR.De-tracing existing reports to reflect the change. Supporting design transfer activities into production.Updating submission documentation, including EU MDR technical documentation and GSP checklists.Hands on qualification testing of the new tablet hardware.Confirming the tablet meets requirements to ship globally – US, EU, and other international markets.Working closely with manufacturing engineers.Supporting design verification and potentially design transfer/implementation activities as the tablet moves towards production release. Troubleshooting/supporting any hiccups during production implementation.Ongoing design verification, design assurance, and MRI/MRA compatibility testing work –proving MR compatibility per DV testing protocols.General compliance-related support as needed. Working toward an FDA/regulatory submission tied to this change.The qualifications for this assignment require a minimum Bachelor in Mechanical Engineering or equivalent or any other related degree

Work Location: Spencer, Indiana 47460

Salary: $54.80/hr

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

Updating design requirements affected by the material change. Running design verification (DV) testing to confirm the new cathode material meets specs.Developing/reviewing verification protocols – sample sizes, test matrices, traceability, acceptance criteria. Analyzing test results and authoring verification reports to support the DHR.De-tracing existing reports to reflect the change. Supporting design transfer activities into production.Updating submission documentation, including EU MDR technical documentation and GSP checklists.Hands on qualification testing of the new tablet hardware.Confirming the tablet meets requirements to ship globally – US, EU, and other international markets.Working closely with manufacturing engineers.Supporting design verification and potentially design transfer/implementation activities as the tablet moves towards production release. Troubleshooting/supporting any hiccups during production implementation.Ongoing design verification, design assurance, and MRI/MRA compatibility testing work –proving MR compatibility per DV testing protocols.General compliance-related support as needed. Working toward an FDA/regulatory submission tied to this change.The qualifications for this assignment require a minimum Bachelor in Pharmacy or equivalent or any other related degree

Work Location: Houston ,Texas 77058

Salary: 57/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

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