Job Description
Job Description
Salary :
Critical Mass Consulting, LLC is a premier dynamic, start-up environment. We believe in our purpose : To develop a company which thrives on connectivity and engagement; to build a premier consulting organization, which rewards creativity, contribution, and growth.
Critical Mass Consulting, LLC is supporting Life Sciences clients in the areas of : Validation Program Development, Periodic Reviews, Risk Assessments, Process Equipment Qualification, Cleaning / Sterilization Validation, Process Validation, and Computerized Systems Validation.
Our company places an emphasis on continuous personal development. This includes support and financing of technical training, mentorship, and the development of high-performance teams.
Job Description :
Critical Mass Consulting, LLC is recruiting a full-time Senior Engineer with Medical Device experience to join our team and work with clients in the Orange County area. If you have a passion for Life Sciences and helping others, we are interested in discussing our company, our process, and what it means to join our team-focused organization.
This position's charter is to serve as the firm's lead subject matter expert in the process design and validation of a novel manufacturing processes for next-generation medical devices. The successful candidate will bridge the gap between cutting-edge manufacturing technology and the rigorous demands of healthcare innovation, leveraging technical expertise to solve complex challenges for our life sciences clients.
This requires a professional who is not only a technical expert but also a consultant, capable of guiding clients through the complexities of adopting and qualifying this transformative technology from the R&D space to clinical support within a regulated GxP framework.
Expected Activities :
Device Process Execution & Optimization
- Independently operate novel device additive manufacturing equipment workflow from R&D activities to Process Validation including associated post-processing equipment; end to end process engineering ensuring design output specifications are suitable for internal and external manufacturing, and process specifications are sufficient to meet design requirements.
- Establish and perform comprehensive material and product testing on devices using both standard and non-standard, novel material testing equipment developed for the verification of CPPs and CQAs.
- Utilize and develop advanced methods to collect, process, and analyze data from cutting-edge metrology techniques (Gage Reproducibility and Reliability), such as optical profilometry, Coordinate Measuring Machines (CMM), and similar high-precision equipment for complex, organic geometries.
GxP Process Development, Qualification & Transfer
Author, maintain, and execute robust protocols for process and equipment qualifications (Installation Qualification - IQ, Operational Qualification - OQ, Performance Qualification - PQ) and support their seamless transfer to client manufacturing teams.Develop, write, and maintain clear, concise, and compliant work instructions and study protocols for all core Process R&D activities and for scaled manufacturing processes, ensuring adherence to Good Documentation Practices (GDP).Serve as the primary author and technical lead for the planning, execution, and documentation of experimental results and analyses intended for global regulatory submissions (e.g., FDA 510(k), CE Mark).Data-Driven Process Analysis & Characterization
Employ advanced statistical tools (e.g., Design of Experiments - DOE, Statistical Process Control - SPC, Analysis of Variance - ANOVA) to rigorously analyze, interpret, and present experimental results to technical and non-technical stakeholders.Lead the study and development of key metrics to explore and define the process capability (e.g.,Cpk,Ppk) of the end-to-end pilot manufacturing process for novel R&D products.Be responsible for the systematic collection, processing, and analysis of orthopedic performance data, exploring and establishing the critical relationship between manufacturing process parameters and final product performance attributes.Serve as the company's and clients' primary Subject Matter Expert (SME) for their Design for Additive Manufacturing (DFAM), providing critical guidance to support robust printing and post-process development.Act as the technical lead for the development of product acceptance metrics, in-process monitoring criteria, and overall process performance criteria.Spearhead all activities related to Test Method Development and Validation (TMDV) for novel characterization techniques required for the additively manufactured product.Success in this consulting role is fundamentally dependent on the ability to operate effectively within a complex ecosystem of stakeholders. The ideal candidate must be a skilled collaborator and systems thinker, capable of integrating their technical work with the broader quality, regulatory, and manufacturing frameworks of our clients.
Work closely and proactively with cross-functional collaborators (e.g., Quality and Operations, and Regulatory Affairs) at client sites to both provide and receive support on major project milestones.Actively problem-solve manufacturing and quality issues with rigorous attention to detail, documenting all activities through risk management (ISO 14971) and within a formal quality system Corrective and Preventive Action (CAPA) system, Change Control, & Exception Management.Provide clear and comprehensive technical requirements for the development and implementation of manufacturing software (e.g., DICOM to print and post).Thrive in a fast-paced, client-focused consulting environment and consistently meet critical project deadlines.Cultural and Foundational Requirements
Alignment with our company's core values and mission is the primary prerequisite for any candidate. We are seeking a professional who is not only technically excellent but also shares our commitment to a people-centric, collaborative, and growth-oriented culture.
Belief in our Core Values. These 4 values provide the foundation for how we operate as a company. With these common shared values, we can effectively accomplish our mission of organizational excellence :People Come First
We Build TogetherEmpowering Growth and Leading People to Make a DifferenceJoy and Discipline, Life in BalanceA strong, demonstrable interest in the Life Sciences and a genuine passion for helping clients and patients.Excellent written and verbal communication skills, with an emphasis on world-class technical writing skills suitable for regulatory review and client consultation.A minimum of 5-7 years of direct technical experience working in the pharmaceutical, medical device, or biotech industry.A Bachelor of Science (B.S.) in Mechanical Engineering, Materials Science, Biomedical Engineering, or a related technical field is required.Solid understanding and experience of design control, risk management and design V&V from early design and development through commercialization as described in ISO 13485, ISO 14971 and FDA Quality System RegulationsDesign for Additive Manufacturing (DFAM) principles and their application to orthopedic or other medical implants is a plus.Experience with process validation (IQ / OQ / PQ) activities for complex manufacturing equipment and processes.Proficiency in statistical analysis software (e.g., Minitab, JMP) and the application of statistical methods to process development and validation.Experience with formal problem-solving methodologies (e.g., Root Cause Analysis) within a CAPA system.