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Engineering / IT / Technology Consultant III

In California / United States

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Engineering / IT / Technology Consultant III   

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JOB TITLE:

Engineering / IT / Technology Consultant III

JOB TYPE:

JOB SKILLS:

JOB LOCATION:

Pittsburg California / United States

JOB DESCRIPTION:

The Director of Biocompatibility Engineering will lead our critical Biocompatibility, Toxicology and Cleaning & Disinfection Programs/teams for the Sleep and Respiratory Care Business.
You are responsible for:
• Formulates and implements long-term functional strategy: steering the team to add maximum value to the business in the future.
• Manages capabilities of the biocompatibility team to develop and maintain a long-term view on the required competences and knowledge to introduce new technology. Ensures that there are adequate resources and tools at the proper time.
• Build and maintain strong connections and relationships with outside Contract Research Organizations, Toxicologists and Consultants for Risk Assessments as needed.
• Develop biocompatibility and sterilization process strategies in consideration of gaps in materials, design, and process to achieve optimal solutions that satisfy
• Lead biological safety initiatives for CAPAs, HHEs, complaints/field actions providing biological safety expertise when required.
• Provide technical and biological leadership and support to development teams.
• Maintain knowledge of medical device regulations to ensure compliance and conformance of programs for evaluation of medical device and other products, including performing gap analysis relevant to changes in biocompatibility standards or guidance.
• Is co-responsible for achieving operational plans, guides Project Managers/Leaders and ensures the optimal allocation of personnel to the projects and effective project management, ensure excellent project execution by constantly optimizing project management practices in the department to exceed customer expectations.
• Ensures appropriate personnel management practices regarding recruitment and selection, adequate staffing, remuneration, performance appraisals, education and training, and management development policy.
• Ensures an engaged, innovative, and inspiring working environment in the department by motivating, challenging, and coaching the department 's employees towards growth, manages and optimizes the innovative climate, stimulating entrepreneurship and driving engagement
• Cooperates with relevant parties outside of the department on a global scale. Works across the borders of the own department – e.g. formulate strategies or project proposals across department borders, cooperating with other department heads, programs and the business. Establishes a network with relevant players; scientific relations outside of the department and with the business - on all topics, and actively using this network to obtain input on technological developments, identifying trends and opportunities.
• Writes, reviews and issues risk assessments, technical reports, technical memoranda, and other documents for internal and external distribution.
• Review and interpret test results for biocompatibility studies
• Make appropriate recommendations and drive the implementation to improve the quality testing activities including product and safety related issues
• Write, review, and approve protocols and reports pertaining to microbiology, sterilization, and/or biocompatibility
• Application of GLP regulations and ISO 10993 Biological Evaluation of Medical Devices
You are a part of:

• Minimum of a Master’s degree in related field, Ph.D. strongly preferred.
• 10+ years’ experience in medical device industry or biocompatibility research organization focused on biocompatibility of medical devices with significant leadership experience.
• Diplomate of the American Board of Toxicology (DABT) certification highly preferred.
• Demonstrated leadership, coaching and development of personnel in diverse and inclusive teams.
• Strong problem solver who is highly organized with the ability to thrive and to lead in an environment with rapidly changing priorities and develop effective and efficient programs or processes to manage ensuing workload for self and team.
• Strong interpersonal skills with an ability to develop solid, long-term relationships and to work effectively in a team setting/matrix-type organization
• Deep working knowledge of ISO 10993 and ISO 18562 standards for biocompatibility, a strong background in regulatory toxicology.
• Proven track record of conducting medical device safety assessment studies, demonstrated ability to manage multiple scientific projects and make sound scientific interpretations and risk assessments.
• Experience coordinating work through outside service laboratories (e.g. extractables/leachable testing and non-clinical safety studies)
• Experience with sample preparation/extraction/ separation techniques for material analyses, polymers and analytical chemistry, and instrumentation analysis – e.g. FTIR, HPLC, GC, IC, ICP-MS, GC/MS spectroscopic techniques
• Experience reading, analyzing, and interpreting common scientific and technical journals/literature, scientific procedures and regulatory guidelines and writing technical reports, toxicological risk assessment or biocompatibility evaluations
• Experience working in a Design Control environment in a Quality Management System.
• Attention to detail and critical thinking skills to Interpret available data and recommend strategies to resolve technical challenges.
• Strong oral and written communication skills

Position Details

POSTED:

Apr 18, 2022

EMPLOYMENT:

INDUSTRY:

SNAPRECRUIT ID:

S16445520090816

LOCATION:

California / United States

CITY:

Pittsburg

Job Origin:

Jobsrus_organic_feed

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In Dallas Fort Worth
Aug 19, 2017 9am-6pm
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Engineering / IT / Technology Consultant III    Apply

Click on the below icons to share this job to Linkedin, Twitter!

The Director of Biocompatibility Engineering will lead our critical Biocompatibility, Toxicology and Cleaning & Disinfection Programs/teams for the Sleep and Respiratory Care Business.
You are responsible for:
• Formulates and implements long-term functional strategy: steering the team to add maximum value to the business in the future.
• Manages capabilities of the biocompatibility team to develop and maintain a long-term view on the required competences and knowledge to introduce new technology. Ensures that there are adequate resources and tools at the proper time.
• Build and maintain strong connections and relationships with outside Contract Research Organizations, Toxicologists and Consultants for Risk Assessments as needed.
• Develop biocompatibility and sterilization process strategies in consideration of gaps in materials, design, and process to achieve optimal solutions that satisfy
• Lead biological safety initiatives for CAPAs, HHEs, complaints/field actions providing biological safety expertise when required.
• Provide technical and biological leadership and support to development teams.
• Maintain knowledge of medical device regulations to ensure compliance and conformance of programs for evaluation of medical device and other products, including performing gap analysis relevant to changes in biocompatibility standards or guidance.
• Is co-responsible for achieving operational plans, guides Project Managers/Leaders and ensures the optimal allocation of personnel to the projects and effective project management, ensure excellent project execution by constantly optimizing project management practices in the department to exceed customer expectations.
• Ensures appropriate personnel management practices regarding recruitment and selection, adequate staffing, remuneration, performance appraisals, education and training, and management development policy.
• Ensures an engaged, innovative, and inspiring working environment in the department by motivating, challenging, and coaching the department 's employees towards growth, manages and optimizes the innovative climate, stimulating entrepreneurship and driving engagement
• Cooperates with relevant parties outside of the department on a global scale. Works across the borders of the own department – e.g. formulate strategies or project proposals across department borders, cooperating with other department heads, programs and the business. Establishes a network with relevant players; scientific relations outside of the department and with the business - on all topics, and actively using this network to obtain input on technological developments, identifying trends and opportunities.
• Writes, reviews and issues risk assessments, technical reports, technical memoranda, and other documents for internal and external distribution.
• Review and interpret test results for biocompatibility studies
• Make appropriate recommendations and drive the implementation to improve the quality testing activities including product and safety related issues
• Write, review, and approve protocols and reports pertaining to microbiology, sterilization, and/or biocompatibility
• Application of GLP regulations and ISO 10993 Biological Evaluation of Medical Devices
You are a part of:

• Minimum of a Master’s degree in related field, Ph.D. strongly preferred.
• 10+ years’ experience in medical device industry or biocompatibility research organization focused on biocompatibility of medical devices with significant leadership experience.
• Diplomate of the American Board of Toxicology (DABT) certification highly preferred.
• Demonstrated leadership, coaching and development of personnel in diverse and inclusive teams.
• Strong problem solver who is highly organized with the ability to thrive and to lead in an environment with rapidly changing priorities and develop effective and efficient programs or processes to manage ensuing workload for self and team.
• Strong interpersonal skills with an ability to develop solid, long-term relationships and to work effectively in a team setting/matrix-type organization
• Deep working knowledge of ISO 10993 and ISO 18562 standards for biocompatibility, a strong background in regulatory toxicology.
• Proven track record of conducting medical device safety assessment studies, demonstrated ability to manage multiple scientific projects and make sound scientific interpretations and risk assessments.
• Experience coordinating work through outside service laboratories (e.g. extractables/leachable testing and non-clinical safety studies)
• Experience with sample preparation/extraction/ separation techniques for material analyses, polymers and analytical chemistry, and instrumentation analysis – e.g. FTIR, HPLC, GC, IC, ICP-MS, GC/MS spectroscopic techniques
• Experience reading, analyzing, and interpreting common scientific and technical journals/literature, scientific procedures and regulatory guidelines and writing technical reports, toxicological risk assessment or biocompatibility evaluations
• Experience working in a Design Control environment in a Quality Management System.
• Attention to detail and critical thinking skills to Interpret available data and recommend strategies to resolve technical challenges.
• Strong oral and written communication skills


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