Company Description
PDV MedTech, formerly known as Phoenix DeVentures, has over 24 years of experience supporting the successful commercialization of medical devices. With facilities in California, Utah, and Colorado, PDV MedTech offers comprehensive services to bring innovative medical solutions to market. The company's established offshore partnerships enable efficient production scaling in cost-effective regions. PDV MedTech is committed to excellence in manufacturing and delivering high-quality medical devices to improve patient care.
Job Description
This position is responsible for providing strong quality and manufacturing engineering expertise in support of new and existing medical device products. The role encompasses developing and implementing quality systems and processes, supporting volume production and new product introductions, designing and validating fixturing and processes, resolving quality and production issues, and facilitating continuous improvement activities — all in full compliance with the company's quality system and applicable regulatory requirements
Responsibilities
- Facilitate new or improved products/processes and the transfer of technology from clinical development to commercialization, interfacing with PDV Operations, R&D, and Quality functions to coordinate compliance and develop best practices.
- Develop and improve existing manufacturing methods, fixtures, assembly aids, and workspace layouts for maximum efficiency.
- Develop and implement Quality System procedures such as SOPs and Work Instructions to support the Quality System.
- Prepare or contribute to validation protocols, manufacturing procedures, product and material specifications, design and development documentation, risk management activities, and task force projects.
- Create verification and validation test protocols and reports, including equipment IQ/OQ/PQ, as required.
- Conduct statistical analysis and generate trend reports; establish sampling plans and develop quality plans on an as-needed basis.
- Perform and document Process Failure Modes and Effects Analysis (PFMEA) and participate in broader risk analysis activities.
- Troubleshoot production issues and implement appropriate solutions; coordinate the reporting, analysis, and resolution of material non-conformance incidents in conjunction with Operations and R&D.
- Coordinate the identification, assignment, monitoring, and completion of product improvement projects within cross-functional teams.
- Conduct process, systems, and supplier quality audits, and drive supplier quality initiatives.
- Evaluate proposed changes at suppliers and to in-house specifications in conjunction with Operations and R&D.
- Assist in resolving internal and external audit findings, non-conformance reports, and corrective actions.
- Train operators on new or modified processes and ensure all production equipment is properly calibrated and maintained.
Skills / Qualifications
- 1–5 years of Quality and/or Manufacturing Engineering experience in the medical device industry, in a regulated environment, or sufficient equivalent work experience.
- Knowledge of FDA regulations, ISO standards, and other applicable international regulatory requirements for medical devices.
- Experience with risk management, design control, manufacturing sterile products, sterilization validation, and CAPA investigations.
- Working knowledge and experience with plastic manufacturing and bonding processes preferred (injection molding, extrusion, reflowing, laminating, etc.).
- Ability to read and interpret engineering drawings, specifications, and statistical sampling plans.
- Experience using dimensional and visual inspection equipment (gage pins, calipers, etc.).
- CAD experience required; SolidWorks preferred.
- Ability to write validation protocols, final reports, and oversee validation activities.
- Excellent problem-solving skills with strong attention to detail and accuracy.
- Effectively prioritizes and manages multiple projects with frequent interruptions.
- Strong verbal and written communication skills; able to collaborate effectively in cross-functional teams and interface well with all levels of the organization.
- Self-directed with good judgment in setting priorities and a strong work ethic.
- Languages: Full professional proficiency in English is the minimum requirement.
