Senior Director, Engineering
Make an impact through innovation that is shaping the future of healthcare.
At Biora, we are focused on creating better ways of developing and delivering life-improving therapeutics.
We continually seek people with the motivation and skills to advance our mission.
As a key member of our Device Development team, the Senior Director of Engineering is responsible for strong fundamental project management leadership expertise coupled with comprehensive technical knowledge of combination medical device development, clinical validation, transfer to manufacture, and the regulatory approval process as well as the driving force for strategic engineering growth.
The successful Senior Director has the strong engineering, scientific, clinical, and regulatory knowledge required to manage multiple combination medical device development projects and manage external partners as well.
This Senior Director will have previous direct experience in the complete development life cycle management from feasibility through commercialization and a strong character to drive projects to completion.
RESPONSIBILITIES Oversees the external development of several medical devices through planning, development, test, verification, optimization, human factors, clinical validation, transfer to manufacture, and familiarity with the regulatory approval process.
Has oversight of management of product development from design to execution.
Drives creation of a seamless transition from design-for-manufacturability to full production.
Provides technical/management leadership to a diverse group of engineering disciplines, including mechanical, electrical, software, systems and project management.
Interacts extensively with all department heads to provide leadership and direction for all business activities.
Meet regularly with department heads to keep informed and to offer direction.
Collaborates with Quality leadership to develop and direct procedures and methods to ensure quality standards are met and maintained throughout the development cycle.
Ensures the company's Quality Policy is understood, implemented and maintained at all levels of the engineering organization.
Drives a culture of accountability based on a project-management driven mentality and approach to meeting milestones within budget.
Oversees project timelines, budgets, and resource needs for each device program.
Develops departmental goals which are aggressive and tied to long-term goals.
Shape and develop company strategy and organization by implementing business processes to ensure consistent and efficient operation within the engineering organization.
Keeps the Sr.
VP of Strategic Pharmaceutical Operations informed about business activities, potential threats, opportunities, and recommended actions.
Oversees the generation and reviews all device history, risk mitigation, and quality documents for the devices required for regulatory filings (i.
e.
, 510k, De Novo 510K and PMA).
Ensures engineering development is performed according to the established device design process and that FDA requirements are being met.
Oversees management of device development to ensure design is manufacturable in high volumes and transfer to manufacture (internal/external) activities.
Oversees/maintains project schedules and activity trackers to ensure timelines are met with Project Management.
Supports accounting and financial aspects of the projects (i.
e.
, budgets, vendors, purchase orders, invoices, accruals).
Assists in selection and performance in vendor management activities when required.
Oversees all engineering team decisions and follows up on action items and deliverables.
Reviews development, verification, validation, and any testing reports for completeness and accuracy.
Oversees action items generated from team meetings and audits to completion.
Manages resources and other duties as they are identified to support cross-functional teams.
Provides direct hands-on design and testing guidance if required This list of duties and responsibilities is not all inclusive and may be expanded to include other duties and responsibilities, as deemed necessary.
REQUIREMENTS Min.
BS in Mechanical, Electrical or Biomedical Engineering.
10
years of experience in a device industry.
10
years of experience demonstrated technical leadership and successful management of engineering teams.
Capable of developing products on time and within budget, preferably in medical devices and drug/device combinations.
Extensive experience in commercializing devices from inception to completion.
Excellent Project Management skills.
Ability to create and manage project plans, budgets, and schedules.
Working knowledge of Medical Device Development Life Cycle and Manufacturing.
CMC knowledge is a plus.
Knowledge and experience in ISO 9001/13485 manufacturing environment are required.
Knowledge and working application of FDA (21 CFR Part 11 and Part 820), IEC 62304.
Experience with statistics, Statistical Process Control and DOE techniques is desirable.
Recognized for being well organized and self-directed with strong interpersonal skills and with an ability to communicate to people at all levels of the organization and lead with influence.
Proactive, forward-thinking, and creative with high ethical standards and a team player with leadership skills and ability to influence others to achieve successful outcomes and meet timelines.
Familiarity with domestic and international regulations and industrial guidance documents (e.
g.
, ISO, FDA guidance and CE Mark requirements).
Energetic individual with can-do attitude and demonstrated team player.
Good interpersonal, follow up, and excellent verbal and written communication skills.
Keen attention to details.
Ability to handle multiple project and priorities with exceptional organizational and time management skills.
Ability to function efficiently, effectively, and at times independently in a fast-paced, changing environment.
Strong team player aligned with Progenity Corporate Values.
Familiarity with drug and/or assay development is a plus.
Proficiency/experience in fluid dynamics is a plus.
Please review the Applicant Privacy Statement for information about how we use the information collected in your application.
Recommended Skills Attention To Detail Auditing Biomedical Engineering Business Processes Clinical Works Commercialization Estimated Salary: $20 to $28 per hour based on qualifications.
At Biora, we are focused on creating better ways of developing and delivering life-improving therapeutics.
We continually seek people with the motivation and skills to advance our mission.
As a key member of our Device Development team, the Senior Director of Engineering is responsible for strong fundamental project management leadership expertise coupled with comprehensive technical knowledge of combination medical device development, clinical validation, transfer to manufacture, and the regulatory approval process as well as the driving force for strategic engineering growth.
The successful Senior Director has the strong engineering, scientific, clinical, and regulatory knowledge required to manage multiple combination medical device development projects and manage external partners as well.
This Senior Director will have previous direct experience in the complete development life cycle management from feasibility through commercialization and a strong character to drive projects to completion.
RESPONSIBILITIES Oversees the external development of several medical devices through planning, development, test, verification, optimization, human factors, clinical validation, transfer to manufacture, and familiarity with the regulatory approval process.
Has oversight of management of product development from design to execution.
Drives creation of a seamless transition from design-for-manufacturability to full production.
Provides technical/management leadership to a diverse group of engineering disciplines, including mechanical, electrical, software, systems and project management.
Interacts extensively with all department heads to provide leadership and direction for all business activities.
Meet regularly with department heads to keep informed and to offer direction.
Collaborates with Quality leadership to develop and direct procedures and methods to ensure quality standards are met and maintained throughout the development cycle.
Ensures the company's Quality Policy is understood, implemented and maintained at all levels of the engineering organization.
Drives a culture of accountability based on a project-management driven mentality and approach to meeting milestones within budget.
Oversees project timelines, budgets, and resource needs for each device program.
Develops departmental goals which are aggressive and tied to long-term goals.
Shape and develop company strategy and organization by implementing business processes to ensure consistent and efficient operation within the engineering organization.
Keeps the Sr.
VP of Strategic Pharmaceutical Operations informed about business activities, potential threats, opportunities, and recommended actions.
Oversees the generation and reviews all device history, risk mitigation, and quality documents for the devices required for regulatory filings (i.
e.
, 510k, De Novo 510K and PMA).
Ensures engineering development is performed according to the established device design process and that FDA requirements are being met.
Oversees management of device development to ensure design is manufacturable in high volumes and transfer to manufacture (internal/external) activities.
Oversees/maintains project schedules and activity trackers to ensure timelines are met with Project Management.
Supports accounting and financial aspects of the projects (i.
e.
, budgets, vendors, purchase orders, invoices, accruals).
Assists in selection and performance in vendor management activities when required.
Oversees all engineering team decisions and follows up on action items and deliverables.
Reviews development, verification, validation, and any testing reports for completeness and accuracy.
Oversees action items generated from team meetings and audits to completion.
Manages resources and other duties as they are identified to support cross-functional teams.
Provides direct hands-on design and testing guidance if required This list of duties and responsibilities is not all inclusive and may be expanded to include other duties and responsibilities, as deemed necessary.
REQUIREMENTS Min.
BS in Mechanical, Electrical or Biomedical Engineering.
10
years of experience in a device industry.
10
years of experience demonstrated technical leadership and successful management of engineering teams.
Capable of developing products on time and within budget, preferably in medical devices and drug/device combinations.
Extensive experience in commercializing devices from inception to completion.
Excellent Project Management skills.
Ability to create and manage project plans, budgets, and schedules.
Working knowledge of Medical Device Development Life Cycle and Manufacturing.
CMC knowledge is a plus.
Knowledge and experience in ISO 9001/13485 manufacturing environment are required.
Knowledge and working application of FDA (21 CFR Part 11 and Part 820), IEC 62304.
Experience with statistics, Statistical Process Control and DOE techniques is desirable.
Recognized for being well organized and self-directed with strong interpersonal skills and with an ability to communicate to people at all levels of the organization and lead with influence.
Proactive, forward-thinking, and creative with high ethical standards and a team player with leadership skills and ability to influence others to achieve successful outcomes and meet timelines.
Familiarity with domestic and international regulations and industrial guidance documents (e.
g.
, ISO, FDA guidance and CE Mark requirements).
Energetic individual with can-do attitude and demonstrated team player.
Good interpersonal, follow up, and excellent verbal and written communication skills.
Keen attention to details.
Ability to handle multiple project and priorities with exceptional organizational and time management skills.
Ability to function efficiently, effectively, and at times independently in a fast-paced, changing environment.
Strong team player aligned with Progenity Corporate Values.
Familiarity with drug and/or assay development is a plus.
Proficiency/experience in fluid dynamics is a plus.
Please review the Applicant Privacy Statement for information about how we use the information collected in your application.
Recommended Skills Attention To Detail Auditing Biomedical Engineering Business Processes Clinical Works Commercialization Estimated Salary: $20 to $28 per hour based on qualifications.
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