-
Senior Quality Engineer
2 weeks ago
Foresite Capital Guilford, United StatesWho We Are · identifeye HEALTH's mission is to democratize healthcare delivery to everyone on a global scale. We are reinventing medical devices to leverage the health information in the human eye and championing a new era of healthcare by creating portable, affordable, easy to ...
-
Sr. Design Quality Engineer
1 week ago
Hyperfine Guilford, United StatesCompany Profile · Hyperfine (NASDAQ: HYPR) is the groundbreaking MedTech company that created Swoop, the world's first FDA-cleared portable magnetic resonance imaging (MRI) system capable of providing neuroimaging at the point of care. Our mission is to transform patient care by ...
-
Quality Engineer
3 weeks ago
SNI Companies Branford, United StatesJob Description · SNI has partnered with a reputable aerospace company near New Haven looking for a Senior Quality Engineer to support their team. · Responsibilities include:Responsible for the overall effectiveness of the plant QMS (Quality Management Systems) · Responsible fo ...
-
Quality Engineer
1 week ago
Complete Staffing Solutions North Haven, United StatesQUALITY ENGINEER · Assist in maintaining ISO 9001 QMS records, system, and document control. · Perform/coordinate periodic ISO department audits · Serve as ISO coordinator for ISO recertification and surveillance audits · Oversee Quality Alert system for internal Quality issues ...
-
Quality Engineer
2 weeks ago
DBSI Services, Inc. North Haven, United StatesJob Title: Quality EngineerLocation: North Haven, CT (Onsite)Job Description: · •Contribute to continuous improvements in overall product cost and quality. · •Participate in DFM / DFA activities assuring that packaging/production processes and equipment are taken into considerati ...
-
Quality Engineer
1 week ago
DBSI Services, Inc. North Haven, United StatesJob Title: Quality Engineer · Location: North Haven, CT (Onsite) · Job Description: · •Contribute to continuous improvements in overall product cost and quality. · •Participate in DFM / DFA activities assuring that packaging/production processes and equipment are taken into c ...
-
Quality Engineer
1 week ago
Futran Solutions North Haven, United StatesJob Title : Quality Engineer · location : North Haven, CT · Qualification: · • BS Degree in Packaging Science, Mechanical Engineering or Equivalent/MS Engineering · • Min 3 yrs. Applicable Experience in packaging engineering, medical devices, pharmaceutical or related industry p ...
-
Quality Engineer
1 day ago
Orion Talent North Haven, United StatesPosition Details: · •Title: Quality Engineer · •Location: North Haven, CT · •Shift: Monday through Friday, daytime hours · •Compensation: $90K to $110K · •Benefits: Medical, Dental, Vision, Retirement, 401K match, PTO, holiday time off, vacation, educational assistance, Life Ins ...
-
Quality Engineer
2 weeks ago
Siri InfoSolutions North Haven, United StatesJob Description · Job Description · Job Title: Quality Engineer · Location: North Heaven, CT · Duration: Full-time · Job Description: · Contribute to continuous improvements in overall product cost and quality. · Participate in DFM / DFA activities assuring that · packaging/pr ...
-
Quality Engineer
1 week ago
Katalyst Healthcares and Life Sciences North Haven, United StatesResponsibilities: Establish and maintain master validation program, including site and individual products and process master validations. Create/Review/Support validation protocols and reports to support process and reliability improvements. Support complaint handling program, i ...
-
Quality Engineer
1 week ago
O F Mossberg & Sons Inc North Haven, United StatesJob Description · Job Description · Job purpose · Under direction of the Director of Quality, perform a wide variety of duties to evaluate manufacturing processes to assess overall quality levels. · Duties and responsibilities · Assist in maintaining ISO 9001 QMS records, sy ...
-
Quality Engineer
4 days ago
O.F. Mossberg & Sons Inc North Haven, United StatesJob Description · Job DescriptionJob purpose · Under direction of the Director of Quality, perform a wide variety of duties to evaluate manufacturing processes to assess overall quality levels. · Duties and responsibilities · Assist in maintaining ISO 9001 QMS records, system, an ...
-
Quality Engineer
4 days ago
Times Microwave Systems Wallingford, United StatesJob Description · Job DescriptionSummary · We are seeking a dynamic and innovative Quality Engineer for a permanent position within our world class manufacturing team. Our customers span commercial aerospace, aeronautics, space, military, and electronics industries. This role is ...
-
Quality Engineer
2 weeks ago
CoWorx Staffing Wallingford, United StatesQuality Engineer Onsite in Wallingford, CT · A respected plastic manufacturer in Wallingford, CT is looking for a Quality Engineer to join their team. The Quality Engineer is responsible for all Quality Assurance / Quality Control processes, including internal auditing, quality ...
-
Quality Engineer
3 weeks ago
Times Microwave Systems Wallingford, United StatesSummary: We are seeking a dynamic and innovative Quality Engineer for a permanent position within our world class manufacturing team. Our customers span commercial aerospace, aeronautics, space, military, and electronics industries. This role is pivotal in maintaining the high st ...
-
Quality Engineer
1 week ago
Marmon Holdings, Inc. West Haven, United StatesKX Technologies LLC · Come join a team where People make the difference As a part of Marmon Holdings, Inc., a highly decentralized organization, we rely heavily on people with the aptitude, attitude, and entrepreneurial spirit to drive our success, and we're committed to attract ...
-
Quality Engineer
1 week ago
Times Microwave Systems Wallingford, United StatesSummary · We are seeking a dynamic and innovative Quality Engineer for a permanent position within our world class manufacturing team. Our customers span commercial aerospace, aeronautics, space, military, and electronics industries. This role is pivotal in maintaining the high ...
-
Quality Engineer
2 weeks ago
Money Fit by DRS Wallingford, United StatesJob Summary · Maintain and continuously improve the Quality Management System to comply with the most current quality system standards. The Quality Engineer is responsible for all Quality Assurance / Quality Control processes, including internal auditing, quality improvement act ...
-
Quality engineer
2 weeks ago
Randstad Wallingford, United Statesjob summary: Permanent Position: Quality Engineer opening in Wallingford, CT. Apply today A manufacturer of high-performance polymers is seeking an engineer with a Bachelor's Degree in an Engineering discipline or an Engineering Associates Degree plus 4 years of experience. Must ...
-
Quality Engineer
2 weeks ago
Parkway Products, LL Wallingford, United StatesJob SummaryMaintain and continuously improve the Quality Management System to comply with the most current quality system standards. The Quality Engineer is responsible for all Quality Assurance / Quality Control processes, including internal auditing, quality improvement activit ...
Sr. Design Quality Engineer - Guilford, United States - Hyperfine
Description
Company ProfileHyperfine (NASDAQ:
HYPR) is the groundbreaking MedTech company that created Swoop, the world's first FDA-cleared portable magnetic resonance imaging (MRI) system capable of providing neuroimaging at the point of care.
Our mission is to transform patient care by creating access to life-saving diagnostics and actionable data at the point of care.
Today, eighty percent of the world's population lacks access to MRI.Hyperfine is on a mission to address the limitations of current imaging technologies and make MR imaging accessible anytime and anywhere.
Do you have a background in magnetic resonance imaging, deep learning, electrical engineering, physics, or related fields? What about health equipment sales, business development, or marketing? Hyperfine lives and works on the cutting edge of medical imaging accessibility.
If you enjoy a challenge as much as you value a committed workplace, we could be the next step in your rising career.
Location:
Guilford, CT Relocation:
Available
SUMMARY:
The Sr.
Design Quality Engineer requires collaboration and successful communication within a cross-functional New Product Development (NPD) team to ensure product performance, safety, compliance, and to achieve business objectives.
The Sr.Design Quality Engineer uses comprehensive knowledge, leadership, and analytical skills to contribute to the development of new products and modification of existing products with the assurance of high quality to meet regulatory and quality requirements, and customer expectations.
This position will have a hands-on role influencing Hyperfine's emerging ideas, advanced technologies, and unique processes.The ideal candidate will have extensive experience and success in developing medical devices, as well as a working knowledge of patient-specific applications and additive manufacturing technologies.
RESPONSIBILITIES:
Lead risk management activities for new and modified products. Develop inspection and sampling plans, test methods, and measurement systems (capability, MSA/gage R&R, etc.). Review and approve design control, quality, manufacturing, engineering, validation, and other technical documentation. Lead development and implementation of quality assurance processes to ensure critical quality attributes are controlled and monitored. Create quality system documentation (procedures, work instructions, FMEAs and RMRs, technical reports, records, memos, and essential requirements). Partner effectively with engineering to ensure product requirements represent user needs and are objective, measurable, and verifiable. Quality representative in design reviews.
Facilitate design transfer and ensure completion of all required quality documentation.
Review and contribute to process risk assessment and process validation.
Resolve technical issues as needed to maintain product quality; owning or a participating team member for NC/CAPAs as required.
Estimate and gather necessary information on timelines and cost related to QA tasks.
Review change notifications to ensure compliance to Quality System, QSR, and international requirements for NPD and Sustaining activities.
All other duties as assigned.
KNOWLEDGE AND SKILL:
Expert in Design Controls and compliance to FDA, cGMP, ISO, ASTM, MDD, and MDR requirements. Advanced knowledge of scientific methods and applied statistics (hypothesis testing, determination of sample size, process capability). Expertise in analytical problem solving and DOE (Design of Experiments). Working knowledge of dimensioning and tolerancing, GD&T. Ability to drive design for manufacturing and inspection as well as usability/human factors engineering principles. Solution-oriented, cooperative, and pragmatic attitude. Effective communication (verbal, written, interpersonal) and conflict resolution skills. Experience with patient-specific multi-use devices required. Experience with Magnetic Resonance Imaging (MRI) and procedures preferred. Solid basic math, problem solving, and deductive reasoning skills.
Dynamic leadership skills; good interpersonal skills; ability to work effectively in a team environment and build strong working relationships, as well as ability to work independently.
Ability to work in a fast-paced environment; ability to work well under pressure and maintain a positive, enthusiastic, and problem-solving attitude.
Computer literate in various software applications (i.e. - Word, Outlook, Visio, Excel, Access, Minitab).Independent organization and prioritization of multiple tasks.EDUCATION/EXPERIENCE REQUIRED:
BS in Engineering (ME, BME preferred) or related technical field. Experience in lieu of education will be considered. 6+ years of related work experience in Engineering or Quality role. 3+ years of experience in team-based medical device product development.
Experience working through all aspects of medical device design, including voice of customer/user needs, design requirements, verification and validation, process validation, and design transfer to manufacturing.
MS in Science preferred. ASQ, CQE or CSSBB preferred.PHYSICAL DEMANDS:
This role is based in Hyperfine's facility in Guilford, CT Able to frequently lift up to 25lb and occasionally up to 50lb.
Able to properly wear PPE (Personal Protective Equipment) required for the area of operation such as gloves, ear protection, eye protection, smocks, etc.
