Development Quality Engineer II
Spectraforce
St. Paul, Minnesota
12 hours ago
Job Description
Job Title: Development Quality Engineer II
Location: St. Paul, MN 55117
Duration: 06 Months
Details:
Position Summary:
We are seeking a Development Quality Engineer II to join our Structural Heart team at our St. Paul, MN location. The individual in this position will assure new or modified products conform to requirements and establish compliance with the quality system. This position is responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. This position will support new product development projects as well as support sustainability of commercially released product. This position may also support manufacturing processes to meet daily production schedules while enhancing productivity and product quality.
Primary Responsibilities:
• Lead on-time completion of project supported Development Quality deliverables and business initiatives.
• Support the definition of objective, measurable, discrete, and verifiable customer requirements, external requirements, and product requirements.
• Lead Risk Management activities from product Concept through Commercialization, including analyzing field data to support new product development, and support Failure Mode Effects Analysis.
• Support Test and Inspection Method development including Method Validation activities.
• Support Design Verification and Design Validation planning and execution, including cross-functional root-cause analysis investigation and resolution activities.
• Support manufacturing process development and qualification for new product commercialization and product changes.
• Accountable for Process Validation planning and execution, including active cross-functional root-cause analysis investigation and resolution activities.
• Identify and implement effective Process Control and monitoring of CTQ parameters and specifications.
• Support, review, and approve Document Change Order and CAPA records in a timely and objective manner.
• Support product builds in the cleanroom for development and commercial activities.
• Be innovative, resourceful, and work with minimal direction. Have excellent organization, problem solving, communication, and team leadership skills. Work effectively with cross-functional teams.
• Build strong collaborative partnerships with cross functional teams including Program Management, Research & Development, and Process Development to ensure cross functional customer needs are met without creating barriers to development cost, time, and scope.
Other Responsibilities:
• Support and ensure internal & external audit responses and on-time product re-certifications.
• Writes and revises SOPs, controlled forms, and related documents to ensure best practices and maintain compliance.
• Participate in Corrective Action/Preventive Action (CAPA) process including the investigation of failures or deviations, as required.
• Additional duties may be identified by functional management based on current project/business objectives.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Required Qualifications:
• Bachelor’s degree within an Engineering field or a closely related discipline.
• 2+ years of engineering experience and demonstrated use of Quality tools/methodologies.
• Solid verbal, written, and interpersonal skills with ability to effectively communicate at multiple levels in the organization.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage and/or engage others to accomplish projects.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.
• Ability to travel occasionally (<5%), including internationally.
Preferred Qualifications:
• Medical device experience with structural heart delivery system development or manufacturing or other intracardiac catheter device development strongly preferred.
• Familiar with 21 CFR Part 820, ISO 13485, ISO 14971, EUMDR, and MDSAP
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 LOA@spectraforce.com 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 NAHR@spectraforce.com.
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: $33.00/hr.
Location: St. Paul, MN 55117
Duration: 06 Months
Details:
Position Summary:
We are seeking a Development Quality Engineer II to join our Structural Heart team at our St. Paul, MN location. The individual in this position will assure new or modified products conform to requirements and establish compliance with the quality system. This position is responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. This position will support new product development projects as well as support sustainability of commercially released product. This position may also support manufacturing processes to meet daily production schedules while enhancing productivity and product quality.
Primary Responsibilities:
• Lead on-time completion of project supported Development Quality deliverables and business initiatives.
• Support the definition of objective, measurable, discrete, and verifiable customer requirements, external requirements, and product requirements.
• Lead Risk Management activities from product Concept through Commercialization, including analyzing field data to support new product development, and support Failure Mode Effects Analysis.
• Support Test and Inspection Method development including Method Validation activities.
• Support Design Verification and Design Validation planning and execution, including cross-functional root-cause analysis investigation and resolution activities.
• Support manufacturing process development and qualification for new product commercialization and product changes.
• Accountable for Process Validation planning and execution, including active cross-functional root-cause analysis investigation and resolution activities.
• Identify and implement effective Process Control and monitoring of CTQ parameters and specifications.
• Support, review, and approve Document Change Order and CAPA records in a timely and objective manner.
• Support product builds in the cleanroom for development and commercial activities.
• Be innovative, resourceful, and work with minimal direction. Have excellent organization, problem solving, communication, and team leadership skills. Work effectively with cross-functional teams.
• Build strong collaborative partnerships with cross functional teams including Program Management, Research & Development, and Process Development to ensure cross functional customer needs are met without creating barriers to development cost, time, and scope.
Other Responsibilities:
• Support and ensure internal & external audit responses and on-time product re-certifications.
• Writes and revises SOPs, controlled forms, and related documents to ensure best practices and maintain compliance.
• Participate in Corrective Action/Preventive Action (CAPA) process including the investigation of failures or deviations, as required.
• Additional duties may be identified by functional management based on current project/business objectives.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Required Qualifications:
• Bachelor’s degree within an Engineering field or a closely related discipline.
• 2+ years of engineering experience and demonstrated use of Quality tools/methodologies.
• Solid verbal, written, and interpersonal skills with ability to effectively communicate at multiple levels in the organization.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage and/or engage others to accomplish projects.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.
• Ability to travel occasionally (<5%), including internationally.
Preferred Qualifications:
• Medical device experience with structural heart delivery system development or manufacturing or other intracardiac catheter device development strongly preferred.
• Familiar with 21 CFR Part 820, ISO 13485, ISO 14971, EUMDR, and MDSAP
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 LOA@spectraforce.com 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 NAHR@spectraforce.com.
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: $33.00/hr.