Explore career opportunities with Fusion. We are actively seeking qualified individuals to join our team. We pride ourselves on fostering a collaborative environment, offering roles that challenge and reward. View our current vacancies for Specific Roles and submit your application to join a leader in Fusion.
Investigating, planning and implementing medical device product improvements and evaluating critical quality manufacturing processes affecting patient safety and product quality. Reduced client device defects and improved production efficiency. Wrote and executed physical test method protocols. Adhered to EU MDR and 21 CFR Part 820, responded to customer complaints, performed audits, developed test methods and validations. Initiated CAPA plans using 5-Why and Fishbone analysis. Conducted dFMEA and pFMEA reviews and updated control plans. Managed NCR/NCMR documentation per ISO 13485. Performed gauge R&R and SPC analysis to monitor Cpk. Issued SCARs and verified supplier corrective actions. Supported EU MDR post-market surveillance and complaint trending. Travel and/or relocation to various unanticipated locations throughout the US may be required.
Master in Mechanical Engineering or Industrial Engineering or Industrial Management or Engineering Management or Engineering Technology or Industrial &Systems Engineering, Master of Science or related
Apply with 2 copies of resume mentioning the position applied to – HR, Fusion Life
Sciences Technologies, LLC
Work Location: 6110 McFarland Station Dr, Suite 502, Alpharetta, GA 30004.
Salary: 109491.00/year
To apply to the position, send your resume to: hr@fusionlifesolutions.com
Sr. Manufacturing Engineer:
Proposes and evaluates manufacturing process and equipment for assigned areas of the plant. Directs the development and improvements in manufacturing projects. Provides technical assistance and training for assigned operations. Works closely with the production team. Analyze tooling and equipment and select proper steps for the solution.Travel and/or relocation to various unanticipated locations throughout the US may be required.
Bachelor's Degree in Mechanical Engineering or Industrial & Systems Engineering or Industrial Management or Engineering Management or Engineering Technology or Pharmacy or Related
Apply with 2 copies of resume mentioning the position applied to – HR, Fusion Life Sciences Technologies
Work Location: 6110 McFarland Station Dr, Suite 502, Alpharetta, GA 30004.
Salary: 125278.00/year
To apply to the position, send your resume to: hr@fusionlifesolutions.com
Investigating, planning and implementing medical device product improvements and evaluating critical quality manufacturing processes affecting patient safety and product quality. Reduced client device defects and improved production efficiency. Wrote and executed physical test method protocols. Adhered to EU MDR and 21 CFR Part 820, responded to customer complaints, performed audits, developed test methods and validations. Initiated CAPA plans using 5-Why and Fishbone analysis. Conducted dFMEA and pFMEA reviews and updated control plans. Managed NCR/NCMR documentation per ISO 13485. Performed gauge R&R and SPC analysis to monitor Cpk. Issued SCARs and verified supplier corrective actions. Supported EU MDR post-market surveillance and complaint trending. Travel and/or relocation to various unanticipated locations throughout the US may be required.
Bachelor's Degree in Pharmacy or Mechanical Engineering or Industrial & Systems Engineering or Industrial Management or Engineering Management or Engineering Technology or Related
Apply with 2 copies of resume mentioning the position applied to – HR, Fusion Life
Sciences Technologies, LLC.
Work Location: 6110 McFarland Station Dr, Suite 502, Alpharetta, GA 30004.
Salary: 125278.00/year
To apply to the position, send your resume to: hr@fusionlifesolutions.com
Develop and implement advanced manufacturing technologies to deliver new product introductions, site capacity expansion, and transformational projects within a regulated medical device manufacturing facility.Design for manufacturability of new product introduction projects from concept through end-to-end process qualification.Responsible for completing engineering tasks in support of an overall project plan.Document and execute equipment and process validations (IQ, OQ, and PQ) for various manufacturing equipment and processes.Create manufacturing work instructions and specifications.Interface with internal and external partners on technical issues, project timelines, and validation support.Ensure compliance with applicable FDA, ISO, quality, safety, and environmental requirements..The qualifications for this assignment require a minimum Bachelor in Mechanical Engineering.Engineering or equivalent or any other related degree
Work Location: Raynham, Massachusetts 02767
Salary: $64/hr
To apply to the position, send your resume to: hr@fusionlifesolutions.com
Acts independently with minimal supervision to execute engineering projects specifically targeting to solve engineering problems related to design practicesDevelop and specify product functional requirements and testing strategies according to user needs, internal and external standards and regulatory requirements.Develop hardware according to system and subsystems requirements, create CAD 3D models and detailed engineering drawings meeting company drafting standards.Identify root causes of issues, determine potential solutions, and evaluate them against requirements.Conduct feasibility studies to estimate product cost and analyze capital equipment, capacity, and capability requirements.Develop and support a wide variety of processing applications such as machining, finishing, forging, casting, cleaning, heat treating, bonding, molding, etc. Maintain and update design history files of fluid system combination products.Lead Operational and Production Qualification execution for medical devices.Participate as an integral member of cross-functional product teams by contributing ideas as well as designing, managing or executing, and interpreting device development activitiesProvide engineering support to evaluate, mitigate, re-certify and maintain compliance of the group’s products with new global regulations.Perform gap analysis of the group’s portfolio of products and technical files with respect to the new regulations.Statistical interpretation of attribute and variable results and Prepare validation summary 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 in Engineering or equivalent or any other related degree
Work Location: Warsaw, IN, 46580
Salary: 51/hr
To apply to the position, send your resume to: hr@fusionlifesolutions.com
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
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