Senior/Principal Mechanical Engineer
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/Principal Mechanical Engineer is responsible for strong fundamental project management expertise coupled with comprehensive technical knowledge of combination medical device development, clinical validation, transfer to manufacture, and the regulatory approval process.
The successful Senior Mechanical Engineer has the strong engineering, scientific, clinical, and regulatory knowledge required to manage multiple combination medical device development projects.
This Senior Mechanical Engineer will have previous direct experience in the complete development life cycle from feasibility through commercialization and a strong character to drive projects to completion.
RESPONSIBILITIES Responsible for the 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.
Contributes to product development from concept to commercialization.
Provides in-depth knowledge of mechanical design, technical requirements and design & development lifecycle knowledge per FDA guidance.
Works on complex issues where analysis of situation or data requires an in-depth evaluation of variable factors.
Analyzes test data using statistical tools, perform in-depth interpretation of results, and generate detailed technical reports.
Conducts research and development of equipment design, tooling/fixture design and manufacturing processes for new production technologies and methods.
Collaborates with Quality Team to ensure procedures and methods to ensure quality standards are met and maintained throughout the development cycle.
Applies creativity and ingenuity to design an innovative system that can be delivered within program constraints.
Ensures that mechanical designs are correct, efficient, safe, robust, and ready for regulatory review.
Works with program managers, and other senior technical staff, to ensure that mechanical and/or systems requirements are clearly articulated.
Oversees the design/implementation of mechanical systems/subsystems from concept phase through design transfer I product launch.
In a non-supervisory capacity, provides coaching, and guidance regarding project tasks to other engineers, designers, technicians and associates.
Prepares documentation to support quality system for design functions (project plans, design input, risk assessment, test protocols and reports, drawing specifications, etc.
) Drives mechanical project timelines and resource needs for device projects.
Directs contribution to all device history, risk mitigation, and quality documents for the devices required for regulatory filings (i.
e.
, 510k, De Novo 510K and PMA).
Assists in selection and performance in vendor management activities when required.
Performs other duties as they are identified to support cross-functional teams.
This list of duties and responsibilities is not all inclusive and may be expanded to include other duties and responsibilities, as deemed necessary.
REQUIREMENTS Be a key driver behind creating a seamless transition from design-for-manufacturability to full production.
Min.
BS in Mechanical or Biomedical Engineering.
7
years experience in device product development, preferably in medical devices and drug/device combinations.
Extensive experience in commercializing devices from inception to completion.
Good Project Management skills.
Working knowledge of Medical Device Development Life Cycle and Manufacturing.
CMC knowledge is a plus.
Design Controls and experience with FDA QSR 21 CFR Part 820 and ISO 13485.
Experience with statistics, Statistical Process Control and DOE techniques is desirable.
7
years working with SolidWorks and ability to create solid models and engineering drawings with a focus on manufacturability.
Creative problem solving and conduct failure analysis and identify critical components.
Understanding of mechanical systems and interaction sub-systems.
Mathematical concepts probability / statistical inference.
Ability to apply mathematical operations.
Ability to present complex engineering designs to project teams, other departments, and senior management.
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.
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.
Experience in computational fluid dynamics, injection molding, FEA simulation, and complex mechanisms.
Please review the Applicant Privacy Statement for information about how we use the information collected in your application.
Recommended Skills Biomedical Engineering Clinical Works Commercialization Computational Fluid Dynamics Coordinating Creative Problem Solving 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/Principal Mechanical Engineer is responsible for strong fundamental project management expertise coupled with comprehensive technical knowledge of combination medical device development, clinical validation, transfer to manufacture, and the regulatory approval process.
The successful Senior Mechanical Engineer has the strong engineering, scientific, clinical, and regulatory knowledge required to manage multiple combination medical device development projects.
This Senior Mechanical Engineer will have previous direct experience in the complete development life cycle from feasibility through commercialization and a strong character to drive projects to completion.
RESPONSIBILITIES Responsible for the 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.
Contributes to product development from concept to commercialization.
Provides in-depth knowledge of mechanical design, technical requirements and design & development lifecycle knowledge per FDA guidance.
Works on complex issues where analysis of situation or data requires an in-depth evaluation of variable factors.
Analyzes test data using statistical tools, perform in-depth interpretation of results, and generate detailed technical reports.
Conducts research and development of equipment design, tooling/fixture design and manufacturing processes for new production technologies and methods.
Collaborates with Quality Team to ensure procedures and methods to ensure quality standards are met and maintained throughout the development cycle.
Applies creativity and ingenuity to design an innovative system that can be delivered within program constraints.
Ensures that mechanical designs are correct, efficient, safe, robust, and ready for regulatory review.
Works with program managers, and other senior technical staff, to ensure that mechanical and/or systems requirements are clearly articulated.
Oversees the design/implementation of mechanical systems/subsystems from concept phase through design transfer I product launch.
In a non-supervisory capacity, provides coaching, and guidance regarding project tasks to other engineers, designers, technicians and associates.
Prepares documentation to support quality system for design functions (project plans, design input, risk assessment, test protocols and reports, drawing specifications, etc.
) Drives mechanical project timelines and resource needs for device projects.
Directs contribution to all device history, risk mitigation, and quality documents for the devices required for regulatory filings (i.
e.
, 510k, De Novo 510K and PMA).
Assists in selection and performance in vendor management activities when required.
Performs other duties as they are identified to support cross-functional teams.
This list of duties and responsibilities is not all inclusive and may be expanded to include other duties and responsibilities, as deemed necessary.
REQUIREMENTS Be a key driver behind creating a seamless transition from design-for-manufacturability to full production.
Min.
BS in Mechanical or Biomedical Engineering.
7
years experience in device product development, preferably in medical devices and drug/device combinations.
Extensive experience in commercializing devices from inception to completion.
Good Project Management skills.
Working knowledge of Medical Device Development Life Cycle and Manufacturing.
CMC knowledge is a plus.
Design Controls and experience with FDA QSR 21 CFR Part 820 and ISO 13485.
Experience with statistics, Statistical Process Control and DOE techniques is desirable.
7
years working with SolidWorks and ability to create solid models and engineering drawings with a focus on manufacturability.
Creative problem solving and conduct failure analysis and identify critical components.
Understanding of mechanical systems and interaction sub-systems.
Mathematical concepts probability / statistical inference.
Ability to apply mathematical operations.
Ability to present complex engineering designs to project teams, other departments, and senior management.
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.
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.
Experience in computational fluid dynamics, injection molding, FEA simulation, and complex mechanisms.
Please review the Applicant Privacy Statement for information about how we use the information collected in your application.
Recommended Skills Biomedical Engineering Clinical Works Commercialization Computational Fluid Dynamics Coordinating Creative Problem Solving Estimated Salary: $20 to $28 per hour based on qualifications.
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