Sr Engineer - Validation and Verification

Job Title: Senior Instrument Verification and Validation Engineer

Duration: 12 Months

Location: Rochester, NY 14626

Schedule: 8:00 AM to 5:00 PM

Job Description:

• Client is seeking a Verification and Validation SR Engineer to help with formal verification and validation of complex medical devices under the regulations of the FDA.
• The individual will be part of an engineering team that is responsible for requirements based manual test case design and execution of test procedures in a BL2 lab environment.
• The team is highly collaborative and will require regular interactions in formal reviews, test planning activities, and working with software development and partners to reproduce and verify system defects.

Responsibilities:

• Designing and implementing software of embedded devices and systems
• Designing, developing, coding, testing, and debugging system software
• Develop Requirements based manual test procedures
• Access requirements for testability and determine best test approach
• Compile and analyze test results
• Document and manage system software defects
• Participate in regular scheduling and team meetings
• Participate in regular off hour meetings with partner in China
• Understand project goals and timelines, and provides support to ensure product launch success
• Perform other work- related duties as assigned.

Required Skills:

• B.S. or M.S. Degree in Computer Science, Chemistry, Biochemistry, Biology, Engineering, or a related discipline required.
• 10+ years required, preferably in a medical device environment.
• Familiarity with software configuration management tools, defect tracking tools, and peer review
• Instrument V&V Theory & Application
• An understanding of IEC 62304 (Medical Device Software – Lifecycle process), ISO 13485, ISO / EN ISO 14971, and FDA QSR experience or equivalent FDA software development requirements
• Good analytical and problem-solving skills
• Good organizational skills, and the ability to manage multiple tasks
• Experience in product development and experimental design
• Ability to work within cross-functional teams
• Strong communication skills, written and verbal
• Must exhibit professionalism, confidence, maturity, desire to succeed, and a self-motivated and proactive orientation.
• Ability to participate in planning and managing projects
• Working knowledge of product development tools and processes (e.g. Design Input, Design Output, Verification and Validation, Product Risk Management)
• Knowledge of related quality systems regulations and processes
• Appropriate computer skills (e-mail, word processing, statistical, spreadsheet and graphing software)
• Knowledge of Application life cycle management (Agile method preferred).
• Know and understand the software test cycle.
• Ability to write test plans, test cases and test reports.
• Occasional travel required.
• The 20% travel includes airplane, automobile travel and overnight hotel.

A job description's work environment section should describe the conditions in which the job applicant will perform their duties. This includes factors that may affect the person's working conditions, such as:

• Temperature: Normal Lab conditions, however, walk in fridge/freezers will be cold.
• Noise level: BL2 lab with a lot of equipment. Can be loud at times
• Exposures: BL2 using real patient samples, controls and reagents.
• Other factors: Overtime is expected. Early or late meetings with China Partners

A job description should include physical demands that are essential to the job's performance to comply with the American with Disabilities Act (ADA). Physical demands are the level and duration of physical exertion needed to perform critical tasks, such as:

• Sitting, Standing, Walking, Lifting, Carrying, Reaching, Pushing, and Pulling.

Other physical demands include:

• Bending
• Crawling
• Stooping
• Vision
• Climbing or balancing
• Kneeling
• Crouching
• Talking or hearing

About Us: Established in 2004, SPECTRAFORCE is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com

Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.

Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at [email protected] if you require reasonable accommodation.

California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting [email protected].

LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.

At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position's starting pay is: $45.00/hr.

Job Title: Senior Instrument Verification and Validation Engineer

Duration: 12 Months

Location: Rochester, NY 14626

Schedule: 8:00 AM to 5:00 PM

Job Description:

• Client is seeking a Verification and Validation SR Engineer to help with formal verification and validation of complex medical devices under the regulations of the FDA.
• The individual will be part of an engineering team that is responsible for requirements based manual test case design and execution of test procedures in a BL2 lab environment.
• The team is highly collaborative and will require regular interactions in formal reviews, test planning activities, and working with software development and partners to reproduce and verify system defects.

Responsibilities:

• Designing and implementing software of embedded devices and systems
• Designing, developing, coding, testing, and debugging system software
• Develop Requirements based manual test procedures
• Access requirements for testability and determine best test approach
• Compile and analyze test results
• Document and manage system software defects
• Participate in regular scheduling and team meetings
• Participate in regular off hour meetings with partner in China
• Understand project goals and timelines, and provides support to ensure product launch success
• Perform other work- related duties as assigned.

Required Skills:

• B.S. or M.S. Degree in Computer Science, Chemistry, Biochemistry, Biology, Engineering, or a related discipline required.
• 10+ years required, preferably in a medical device environment.
• Familiarity with software configuration management tools, defect tracking tools, and peer review
• Instrument V&V Theory & Application
• An understanding of IEC 62304 (Medical Device Software – Lifecycle process), ISO 13485, ISO / EN ISO 14971, and FDA QSR experience or equivalent FDA software development requirements
• Good analytical and problem-solving skills
• Good organizational skills, and the ability to manage multiple tasks
• Experience in product development and experimental design
• Ability to work within cross-functional teams
• Strong communication skills, written and verbal
• Must exhibit professionalism, confidence, maturity, desire to succeed, and a self-motivated and proactive orientation.
• Ability to participate in planning and managing projects
• Working knowledge of product development tools and processes (e.g. Design Input, Design Output, Verification and Validation, Product Risk Management)
• Knowledge of related quality systems regulations and processes
• Appropriate computer skills (e-mail, word processing, statistical, spreadsheet and graphing software)
• Knowledge of Application life cycle management (Agile method preferred).
• Know and understand the software test cycle.
• Ability to write test plans, test cases and test reports.
• Occasional travel required.
• The 20% travel includes airplane, automobile travel and overnight hotel.

A job description's work environment section should describe the conditions in which the job applicant will perform their duties. This includes factors that may affect the person's working conditions, such as:

• Temperature: Normal Lab conditions, however, walk in fridge/freezers will be cold.
• Noise level: BL2 lab with a lot of equipment. Can be loud at times
• Exposures: BL2 using real patient samples, controls and reagents.
• Other factors: Overtime is expected. Early or late meetings with China Partners

A job description should include physical demands that are essential to the job's performance to comply with the American with Disabilities Act (ADA). Physical demands are the level and duration of physical exertion needed to perform critical tasks, such as:

• Sitting, Standing, Walking, Lifting, Carrying, Reaching, Pushing, and Pulling.

Other physical demands include:

• Bending
• Crawling
• Stooping
• Vision
• Climbing or balancing
• Kneeling
• Crouching
• Talking or hearing

About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com

Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.

Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at [email protected] if you require reasonable accommodation.

California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting [email protected].

LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.

At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position's starting pay is: $45.00/hr.