DNAe, the inventors of semiconductor-based next-generation sequencing (NGS) technology, is developing a revolutionary new platform that enables NGS-based diagnostic capability in an easy to use, cartridge-based system that will allow direct from clinical specimen to clinically relevant, actionable results in a matter of hours.
Job Description
We are seeking a highly motivated Lead Engineering Technician to join our dynamic team in the field of medical device development. As the Lead Engineering Technician, you will be part of a cross-functional team, and play a crucial role in supporting the design, development, testing, and manufacturing of innovative medical devices both individually and through leading a team of Engineering Technicians. Your expertise and technical acumen will contribute to the success of our product development initiatives, ensuring the delivery of safe, effective, and compliant medical devices that positively impact patient care.
Responsibilities
Technical leadership: Serve as a lead technician within the engineering team, providing leadership and technical guidance and support to junior technicians. Collaborate closely with engineers and project managers to execute product development plans and achieve project objectives. Coordination and delegation of tasks for prototype instrument builds and updates.
Prototyping and Testing: Utilize your strong technical skills to build and test prototypes of medical devices, ensuring adherence to design specifications, safety regulations, and quality standards. Analyze and interpret test results, providing recommendations for improvements and modifications as needed.
Documentation and Reporting: Maintain accurate and comprehensive documentation throughout the development process, including test reports, engineering change orders, and equipment calibration records. Prepare clear and concise technical reports to communicate findings, observations, and recommendations to stakeholders.
Equipment and tooling: Oversee the maintenance, calibration, and organization of laboratory equipment, tools, and supplies required for product development activities. Ensuring that equipment is in optimal working condition, troubleshoot issues, and coordinate repairs or replacements when necessary.
Process Optimization: Collaborate with engineers and manufacturing personnel to identify areas for process improvement and optimization. Participate in continuous improvement initiatives, suggest enhancements to workflows, procedures, and manufacturing techniques to increase efficiency and productivity.
Compliance and Regulatory Standards: Ensure adherence to compliance regulatory requirements, industry standards, and best practices throughout the development process. Collaborate with regulatory affairs and quality assurance teams to support compliance efforts and prepare documentation for regulatory submission.
Cross functional collaboration: Collaborate with cross-functional teams including engineering, R&D, quality, regulatory, and manufacturing, to facilitate seamless communication and knowledge transfer. Participate in design reviews, team meetings, and project discussions to contribute valuable insight and recommendations.
Training and Mentoring: Provide training and mentoring to junior engineering technicians, fostering their technical skills and professional development. Share knowledge and best practices, ensuring the growth and success of the engineering team.
Qualifications & Experience Required:
High School Diploma required, AS or technical degree preferred with 7+ years industry experience in
life sciences, mechanical workshop, physical test laboratory, medical or precision industry
manufacturing, or B.S. in Bioengineering, Mechanical Engineering, or other relevant fields with 3+ years industry experience.
Qualifications include: • Extensive experience as a Lead Engineering Technician within the Medical device, IVD or related
regulated environment (i.e., ISO 13485). • Experience investigating and solving problems with complex instrumentation. • Multi-skilled in the assembly of electro-mechanical R&D devices, rigs, and fixtures. • Proficient in preventive maintenance of instrumentation. • Practical experience in rapid prototyping techniques (e.g., CNC milling, 3D printing, laser cutting,
plastic bonding techniques). • Practical experience in soldering and wiring electrical components and sensors. • Knowledgeable in CAD (SolidWorks) and other industry standard issue tracking software tools
(Trello/JIRA). • Able to communicate technical knowledge in a clear and understandable manner. • Capable of drafting and following SOP, WI, and reports. • Proficient of Microsoft Packages (MS Word, Excel, PowerPoint). • Experience working in a wet lab or ideally BSL-2 environment. • Capable of leading projects ensuring deliverables are achieved on time. • Diligence and attention to detail.
Apply
If you believe you meet the above criteria and would relish playing a key role in developing a revolutionary technology, we would be delighted to hear from you.
We offer a competitive compensation package to successful candidates.
Please email your CV and cover letter to: HR-US@dnae.com quoting
Your name and thejob title in the subject line.
For more information about DNAe, please visit our website www.dnae.com
DNAe is committed to offering staff a competitive remuneration package, alongside compelling benefits. As the primary part of the process, we conduct a rigorous market data review where each role is individually benchmarked using a vast amount of recent data. The estimated base salary range for the Lead Engineering Technician role based in Carlsbad, California is: $88,000 to $95,000. Compensation decisions are dependent on several factors including, but not limited to, an individual's qualifications, location where the role is to be performed, internal equity, and alignment with market data. Should the level or location of the role change during the hiring process, the applicable salary range may be updated accordingly.
DNAe, Inc. is an equal opportunity employer that does not discriminate on the basis of race, color, national origin, ancestry, religion, sex, gender, age, marital status, physical or mental disability, military or veteran status, sexual orientation, gender identity, gender expression, genetic information, or any other characteristic protected by applicable federal, state or local law.