Apply on Employer Site

SEC Group · 4 hours ago

Research And Development Engineer

Thousand Oaks, CA

Full-time

Onsite

Senior Level

$120K/yr - $130K/yr

7+ years exp

SEC Group is seeking a Senior Research and Development Engineer to lead the research, design, and development of components for critical bioprocessing applications. This role involves supporting innovation and product development through all stages, ensuring compliance with regulatory standards, and driving continuous improvement in product performance.

Staffing & Recruiting

Hiring Manager

Brendan Brown

Responsibilities

Translate business needs and market trends into product requirements and innovative engineering solutions

Stay current with emerging technologies, materials, and industry trends to maintain competitive advantage

Drive innovation by exploring new technologies, tools, and methodologies

Support intellectual property strategies by identifying patentable technologies, working with legal team

Partner with cross-functional teams to ensure successful product development and launch, adhering to established stage-gated process and governance model

Effectively project manage timelines, budgets, and resources to deliver high-quality results

Oversee the planning, design, development, prototyping, testing, and validation of new products and technologies

Conduct risk assessments using FMEA framework, and drive risk mitigations as required. Lead design and drawing reviews as needed

Ensure compliance with applicable regulatory, safety, and quality standards throughout the development process

Lead problem-solving, corrective, and preventative actions around product concerns originating both external and internal to the organization

Analyse data from validation tests to determine whether systems and processes meet required criteria and specifications

Maintain technical records within design history files

Drive continuous improvement in product performance, design for manufacturability (DFM), and design for cost-effectiveness (DTC)

Develop and implement engineering best practices, design standards, and documentation protocols. Author SOP’s, Work Instructions and Templates

Support Product Delivery Teams (PDT), including creating and or reviewing quality documents, participating in Corrective And Preventive Action (CAPA) implementation, and generating or supporting ECR (Engineering Change Request) & ECO (Engineering Change Order) activities

Work with Scientists and Engineers internally and externally to assess and develop appropriate design and manufacturing specifications

Perform other duties as assigned

Qualification

Single-Use Technology (SUT) designDesign of molded plastic partsRegulatory guidelines knowledgeProduct development expertiseCAD software proficiencyPrototyping technologiesData analysis skillsProject managementCommunication skillsInterpersonal skillsAttention to detailSelf-motivatedTeam collaboration

Required

Bachelor's degree in Mechanical, Electrical, Biomedical, or related Engineering field

7+ years of engineering experience within a biotechnology or pharmaceutical manufacturing facility

4+ years of Single-Use Technology (SUT) design experience

Demonstrated expertise in the design of molded plastic parts and assemblies for fluid handling of leak-proof applications

Thorough understanding of industry standards and regulatory guidelines

Proven track record in product development, from concept through commercialization

Ability to manage multiple projects in a fast-paced, collaborative environment

Results-driven mindset with keen sense of urgency and ability to deliver ahead of deadlines

Demonstrated attention to detail

Excellent follow-up skills

Must be self-motivated, amendable to a variety of work projects and work efficiently independently and as part of a team

Strong knowledge of design controls, prototyping technologies such as 3D printing, testing, and validation methodologies

Able to read and comprehend and interpret documents such as drawings, BOM's, blueprints, and operating procedures

Maintain organized and controlled records of all drawings and BOM's

Solid understanding of mathematical fundamentals of plane and solid geometry, fractions, percentages, ratios, and proportions applied to practical situations

Ability to interpret complex data sets, identify patterns, and draw meaningful conclusions

Expert knowledge and demonstrated hands-on experience with CAD software, both 3D and 2D

Proficient with Microsoft Office Suite or related software

Excellent verbal and written communication skills

Strong interpersonal skills: ability to interact with staff at all levels within the organization

Proactive approach to identifying opportunities for improvement and driving positive change

Develop and maintain positive rapport and working relationships with other personnel across the organization in support of initiatives to execute product improvements and enhancements

Experience working in a GMP (Good Manufacturing Practice) or laboratory environment