Research And Development Manager

3 months ago

Carlsbad, United States Bolt Medical Full time

DIRECT CANDIDATES ONLY, IF INTERESTED APPLY THROUGH JOB POST. NO DIRECT MESSAGES.

RECRUITERS: DO NOT CONTACT.


Responsibilities:

Overall:

  • 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.


Qualifications:

Education & Experience:

  • Engineering degree desired or equivalent experience in related job field
  • 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

Skills & 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.

  • Research Development Manager

    2 weeks ago

    Carlsbad, United States BioPhase Solutions Full time

    **About Us:** BioPhase Solutions is a leading company in the field of pharmaceutical development.We are seeking an experienced Sr Research Associate to join our team.The estimated salary for this position is $120,000 - $180,000 per year.Job Description:Conduct routine and non-routine analysis of in-process, toxicology, finished drug substance and drug...

  • Veterinary Research Scientist

    2 weeks ago

    Carlsbad, United States RPM ReSearch Full time

    Company OverviewRPM ReSearch is a premier R&D service provider for the life sciences sector. We cover the entire drug discovery, preclinical, and clinical development process across various therapeutic modalities.About the RoleWe are seeking a highly skilled Veterinary Research Scientist to support our in vivo research models. This pivotal role involves...

  • Surgical Research Expert

    2 weeks ago

    Carlsbad, United States RPM ReSearch Full time

    **Job Overview:**We are seeking a highly skilled Veterinary Scientist to lead the development and maintenance of in vivo models for preclinical studies. This critical role involves supporting the development of surgical techniques, dosing, and sampling methods.**Key Responsibilities:- Develop and support in vivo models for screening therapeutics and...

  • Research Scientist and Director of Cell Therapy Initiatives

    13 hours ago

    Carlsbad, United States RPM ReSearch Full time

    Key ResponsibilitiesWe are seeking a visionary Research Scientist & Study Director to lead our in-vivo studies focused on cell and gene therapy. As part of our talented team, you will oversee the conduct, interpretation, documentation, and reporting of pivotal studies.Your responsibilities will include:Providing technical excellence in study design,...

  • Veterinary Research Scientist/ Senior Scientist

    1 day ago

    Carlsbad, United States RPM ReSearch Full time

    Job DescriptionJob DescriptionJob Title: Veterinary Research ScientistPrimary Responsibilities:This position requires a broad knowledge of the anatomy and physiology of small and large animals to help develop and support in vivo models to screen therapeutics and devices being developed for various disorders. Experience with surgical, dosing and sampling...

  • Clinical Research Coordinator

    2 days ago

    Carlsbad, United States Profound Research Full time

    The Company Profound enables community physicians to offer clinical research as a therapeutic option to their patients. We provide all the infrastructure, non-clinical services, and administrative heavy lifting. The physicians practice medicine, we do everything else, and patients get access to the newest therapies available. Mission, Vision, Values o...

  • Preclinical Development Expert

    2 weeks ago

    Carlsbad, United States RPM ReSearch Full time

    Surgical Study Director OpportunityWe are a leading R&D service provider for the life sciences sector, and we are seeking an experienced Surgical Study Director to join our team. In this role, you will play a critical part in developing and maintaining in vivo research models to screen therapeutics and devices for various disorders.As a Surgical Study...

  • Clinical Research Coordinator

    7 days ago

    Carlsbad, United States Profound Research Full time

    The Company Profound enables community physicians to offer clinical research as a therapeutic option to their patients. We provide all the infrastructure, non-clinical services, and administrative heavy lifting. The physicians practice medicine, we do everything else, and patients get access to the newest therapies available. Mission, Vision, Values o...

  • Animal Model Developer

    2 weeks ago

    Carlsbad, United States RPM ReSearch Full time

    **Job Description:**We are seeking a highly skilled Veterinary Scientist to lead the development and maintenance of in vivo models for preclinical studies. This pivotal role involves providing surgical support and expertise in anesthesia, surgical procedures, and analgesics.**Responsibilities:- Develop and support in vivo models for screening therapeutics...

  • Sr. Director of Research and Development

    2 weeks ago

    Carlsbad, United States Bolt Medical Full time

    DIRECT CANDIDATES ONLY, IF INTERESTED APPLY THROUGH JOB POST. NO DIRECT MESSAGES.RECRUITERS: DO NOT CONTACT.Responsibilities:Overview: We are seeking an experienced and visionary Senior Director of Catheter Engineering to lead our research and development team focused on designing the next generation of laser-based intravascular lithotripsy systems. The...

  • Sr. Director of Research and Development

    3 months ago

    Carlsbad, United States Bolt Medical Full time

    DIRECT CANDIDATES ONLY, IF INTERESTED APPLY THROUGH JOB POST. NO DIRECT MESSAGES.RECRUITERS: DO NOT CONTACT.Responsibilities:Overview: We are seeking an experienced and visionary Senior Director of Catheter Engineering to lead our research and development team focused on designing the next generation of laser-based intravascular lithotripsy systems. The...

  • Research and Development Coordinator I

    4 weeks ago

    Carlsbad, United States Della Infotech Full time

    **Della Infotech** seeks a talented Clinical Research Associate to support the development of our in vitro diagnostics. This role requires strong organizational skills, attention to detail, and excellent communication abilities.As a Clinical Research Associate, you will work closely with our Regulatory and Clinical Affairs team to ensure that our products...

  • Research and Development Engineer Trainee

    2 weeks ago

    Carlsbad, United States STR Full time

    About STRAt STR, we specialize in advanced research and development for defense, intelligence, and national security. Our team of experts works on cutting-edge projects related to cyber, next-generation sensors, radar, sonar, communications, and electronic warfare. We also focus on artificial intelligence algorithms and analytics to make sense of the...

  • Chemist (3148)

    4 days ago

    Carlsbad, United States Navarro Research and Engineering Full time

    Description Navarro Research and Engineering, Inc. is hiring a temporary Chemist with an estimated 1,000 hours of work. Travel is potential. Navarro Research & Engineering is an award-winning federal contractor dedicated to partnering with clients to advance clean energy and deliver effective solutions for complex challenges in the nuclear and environmental...

  • Senior Clinical Research Associate, Early Clinical Development

    3 days ago

    Carlsbad, United States IQVIA Full time

    IQVIA Biotech is hiring for our Early Clinical Development team. Ideal candidates will have Phase 1 Experience across a variety of therapeutics (prefer Cell & Gene Therapy & Alzheimer's Disease). Seeking candidates on the West Coast or Centrally located, US. Job Overview Perform monitoring and site management work to ensure that sites are conducting the...

  • Research Scientist

    4 weeks ago

    Carlsbad, United States Pharmaron Full time

    Job Summary:">We are seeking a highly motivated and skilled In Vivo Research Associate I, II or III to join our team at Pharmaron. This role will involve supporting in vivo studies to test medical devices, requiring a broad knowledge of animal anatomy, hands-on experience with large animals, physiology, and surgery.">About the Role:">This is an exciting...

  • Clinical Research Associate

    2 weeks ago

    Carlsbad, United States Della Infotech Full time

    We are seeking a skilled Clinical Research Associate to join our team at Della Infotech. The ideal candidate will have a strong background in biology, chemistry, or bio-engineering and excellent knowledge of Good Clinical Practices (GCP). In this role, you will be responsible for coordinating and conducting clinical research studies for in vitro diagnostics,...

  • Chemist (3148)

    4 days ago

    Carlsbad, United States Navarro Research Full time

    Navarro Research and Engineering, Inc. is hiring a temporary Chemist with an estimated 1,000 hours of work. Travel is potential.Navarro Research & Engineering is an award-winning federal contractor dedicated to partnering with clients to advance clean energy and deliver effective solutions for complex challenges in the nuclear and environmental fields....

  • Marketing Associate

    4 days ago

    Carlsbad, United States ScienCell Research Laboratories Full time

    ScienCell Research Laboratories (http://www.sciencellonline.com) is a biotechnology company whose mission is the research and development of cell and cell-related products for experimental and therapeutic use. Due to the rapid expending of our business, we currently have a new opening:Marketing AssociateCode 1402The marketing associate will be responsible...

  • Marketing Associate

    4 days ago

    Carlsbad, United States ScienCell Research Laboratories Full time

    ScienCell Research Laboratories (http://www.sciencellonline.com) is a biotechnology company whose mission is the research and development of cell and cell-related products for experimental and therapeutic use. Due to the rapid expending of our business, we currently have a new opening:Marketing AssociateCode 1402The marketing associate will be responsible...