Job Description
DIRECT CANDIDATES ONLY, IF INTERESTED APPLY THROUGH JOB POST. NO DIRECT MESSAGES.
RECRUITERS: DO NOT CONTACT.
Position Overview: Provides supervision and technical leadership to development engineering employees who are responsible for planning, developing, and coordinating new therapeutic device development projects. The R&D manager works cross-functionally to ensure that the therapeutic device development program priorities are determined and met, logistics are effectively coordinated, and budgets are adhered to. The manager is also responsible for interfacing with physician users to define system requirements, follows competitive product activity, and develops innovative new technologies to meet market demands while maintaining quality standards.
Responsibilities:
- Lead engineering team in support of product development and ensure all work is performed per internal, ISO and regulatory standards.
- Ensure execution of detailed engineering analyses & documentation to support design development and support process transfer
- Apply Project Management tools to track, trend, communicate and drive projects to meet deliverables.
- Compiles high level timeline and resource needs. Creates, tracks, and meets project schedules, plans, and budgets.
- Directs and implements a comprehensive product development strategy.
- Coordinates all aspects of product development activities of R&D/Product Development, including integration of RA, QA, Operations, and Clinical.
- Participates as team leader or as an active member of the team to meet company objectives and ensure department responsibilities are completed.
- Assesses priorities and makes assignments to direct reports to ensure project and company priorities are met.
- Performs supervisory responsibilities for direct reports, including but not limited to, performance reviews, recommending salaries and promotions, training, interviewing, and hiring decisions and disciplinary actions
- Identifies development needs and potentials of employees and provides or recommends project assignments and training to increase expertise to meet current or future needs.
- Provides technical support and feedback for direct reports.
- Actively participates in training and providing input to training of employees on department procedures and policies
- Coordinates with team members, internal and external suppliers and outside professionals to ensure project output meet users’ needs as well as applicable regulatory requirements
- Provides input, feedback, and maintenance for department and/or company procedures and policies.
- Oversee design transfer from R&D to Manufacturing
- Produce and manage plans, reports, specifications, SOPs, forms, and other documentation to support Manufacturing and/or Manufacturing Development activities. Generates, reviews, and approves documents, including standard operating procedures, batch records, material specifications, and validation protocols / reports.
- Ensures processes, documents, materials, and equipment are compliant with applicable regulatory requirements including ISO13485, ISO 14971 and cGMP.
- Work closely with QA to maintain compliance
- Participates in investigations related to Nonconformance and/or Corrective and Preventive Actions related to manufacturing
- Support Regulatory Submissions.
- Identifying and mitigating risks in manufacturing operations that could negatively impact delivery of safe and effective products to patients.
Requirements
- Bachelor’s degree in Engineering, Life Sciences, or a related field; advanced degree preferred.
- Proven experience in supervising research teams and managing projects effectively.
- Strong background in clinical research methodologies, including experience with clinical trials.
- Familiarity with laboratory techniques and scientific research principles.
- Excellent leadership skills with the ability to motivate team members towards common goals.
- Proficient in data collection methods and statistical analysis relevant to clinical studies.
- Knowledge of Good Clinical Practice (GCP) standards is highly desirable.
- Strong communication skills, both verbal and written, to convey complex information clearly.
Education
- Engineering degree desired or equivalent experience in related job field
Required Experience
- 8+ years related experience in Design/R&D or manufacturing environment and 2+ years of managerial level experience
- At least 5 years of relevant experience working under FDA QSR/ISO 13485 and GMP regulations. Experience working in a Medical Device or regulated industry preferred
- Experience with risk assessment ISO 14971.
- Familiarity with auditing practices.
- Proven track record in technology development and/or early-stage R&D; capable of articulating a strategy for progressing towards a loosely defined research goal
- Experience with IQ/OQ/PQ
Knowledge, Skills and Abilities:
- Strong data analysis and troubleshooting skills.
- Continual improvement process experience.
- Strong organizational and communication skills, including technical writing.
- Expert level knowledge with new product development process and demonstrated experience leading products from concept to commercialization.
- Strong working knowledge of Medical Device Design Control regulations/requirements
- Ability to work well with people at all levels.
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