Overview
On Site
$49
Contract - W2
Contract - 12 Month(s)
Skills
CAD
FDA
ISO
Job Details
DivIHN (pronounced divine ) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.
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For further inquiries regarding the following opportunity, please contact our Talent Specialist
Hema Malini at
Hema Malini at
Title: Principal Engineer Disposables R&D, Sustaining (Hybrid)
Location: Plymouth, MN
Duration: 12 Months
Position can be remote/hybrid but you must be local and able to come into the office at least three days a week
Description:
Summary: This section focuses on the main purpose of the job in one to four sentences.
Leads design and development of product changes within sustaining engineering for disposable medical devices.
Essential Duties and Responsibilities: This section contains a list of primary responsibilities of this role that account for 5% or more of the work. The incumbent will perform other duties assigned.
Schedule, budget, and lead engineering projects with minimal guidance.
Serve as the technical expert for design change programs. (e.g. new products, suppliers, materials, labeling, CAPA/NCR, cost reduction, remediation).
Identify, investigate, and solve complex engineering problems utilizing risk-based and customer focused approaches and engineering tools. (e.g. dFMEA, Human Factors Engineering, statistical software, CAD).
Lead the creation and maintenance of design history files.
Coordinate and communicate the efforts of R&D in collaboration with global cross-functional stakeholders.
Adhere to design control procedures, general safety rules, company policies and procedures, FDA and international regulations and guidance.
May supervise engineers and/or technicians.
May contribute to Client's intellectual property through invention disclosures and patent applications.
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
Advanced knowledge of plastics materials and processing such as injection molding, extrusion, ultrasonic welding, UV/solvent bonding, and sterilization.
Advanced knowledge of FDA Design Controls and ISO 13485 Quality Management Systems.
Working knowledge of CAD design and PDM enterprise software (e.g. Creo, Solidworks).
Working knowledge of ANSI/AAMI/ISO 14971 Medical Devices - Application of Risk Management to Medical Devices.
Creative Problem Solver identify technical risks up front, develop and execute mitigations and provide team direction on how to remove or avoid roadblocks.
Takes initiative with a high aptitude for learning, innovation, and implementing best practices and continuous improvements.
Ability to train and coach others from technical expertise.
Self-directed, resourceful, and able to manage multiple priorities.
Strong interpersonal, communication, collaboration and influencing skills.
Ability to read, write and comprehend English.
Experience and/or Background BS in Mechanical, Plastics, Biomedical Engineering or a related field, MS preferred.
5 - 8 years of related experience in Class II or Class III disposables medical product development.
Summary: This section focuses on the main purpose of the job in one to four sentences.
Leads design and development of product changes within sustaining engineering for disposable medical devices.
Essential Duties and Responsibilities: This section contains a list of primary responsibilities of this role that account for 5% or more of the work. The incumbent will perform other duties assigned.
Schedule, budget, and lead engineering projects with minimal guidance.
Serve as the technical expert for design change programs. (e.g. new products, suppliers, materials, labeling, CAPA/NCR, cost reduction, remediation).
Identify, investigate, and solve complex engineering problems utilizing risk-based and customer focused approaches and engineering tools. (e.g. dFMEA, Human Factors Engineering, statistical software, CAD).
Lead the creation and maintenance of design history files.
Coordinate and communicate the efforts of R&D in collaboration with global cross-functional stakeholders.
Adhere to design control procedures, general safety rules, company policies and procedures, FDA and international regulations and guidance.
May supervise engineers and/or technicians.
May contribute to Client's intellectual property through invention disclosures and patent applications.
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
Advanced knowledge of plastics materials and processing such as injection molding, extrusion, ultrasonic welding, UV/solvent bonding, and sterilization.
Advanced knowledge of FDA Design Controls and ISO 13485 Quality Management Systems.
Working knowledge of CAD design and PDM enterprise software (e.g. Creo, Solidworks).
Working knowledge of ANSI/AAMI/ISO 14971 Medical Devices - Application of Risk Management to Medical Devices.
Creative Problem Solver identify technical risks up front, develop and execute mitigations and provide team direction on how to remove or avoid roadblocks.
Takes initiative with a high aptitude for learning, innovation, and implementing best practices and continuous improvements.
Ability to train and coach others from technical expertise.
Self-directed, resourceful, and able to manage multiple priorities.
Strong interpersonal, communication, collaboration and influencing skills.
Ability to read, write and comprehend English.
Experience and/or Background BS in Mechanical, Plastics, Biomedical Engineering or a related field, MS preferred.
5 - 8 years of related experience in Class II or Class III disposables medical product development.
About us:
DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.
DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.