Sr. Engineer â Disposables R&D, Sustaining (Hybrid)
Sr. Engineer â Disposables R&D, Sustaining (Hybrid)
Posted on :
23-06-2025
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1 Vacancy
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Job Description
For further inquiries regarding the following opportunity please contact our Talent Specialist
Meghna at
Meghna at
Title: Sr. Engineer Disposables R&D Sustaining (Hybrid)
Location: Plymouth MN
Duration: 12 Months
It is an onsite role at least 3 days a week Tuesday Wednesday and Thursday. Rest days are remote.
Description:
Summary:
- This section focuses on the main purpose of the job in one to four sentences.
- Supports 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.
- Lead and support small to medium sized projects with global cross-functional teams in the implementation of design changes (e.g. new features suppliers materials labeling CAPA/NCR cost reduction remediation).
- Identify investigate and solve engineering problems utilizing risk-based and customer focused approaches and engineering tools. (e.g. dFMEA Human Factors Engineering statistical software CAD).
- Create modify and maintain design history file documentation including protocols reports design specifications labeling and design drawings.
- Develop and execute test method validations product testing and verification / validation activities.
- Build prototypes and models. May operate machine tools design and build basic tooling test fixtures and assembly equipment.
- Adhere to design control procedures general safety rules company policies and procedures FDA and international regulations and guidance.
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 accommodation may be made to enable individuals with disabilities to perform essential functions.
- Working knowledge of plastics materials and processing such as injection molding extrusion ultrasonic welding UV/solvent bonding and sterilization.
- Working knowledge of CAD and PDM enterprise software (e.g. Creo Solidworks).
- Working knowledge of FDA Design Controls and ISO 13485 Quality Management Systems.
- Working knowledge of ANSI/AAMI/ISO 14971 Medical Devices - Application of Risk Management to Medical Devices.
- Takes initiative with a high aptitude for learning innovation and implementing best practices and continuous improvements.
- Strong collaboration verbal and written communication skills.
- Strong attention to detail organized and able to independently manage multiple priorities.
- Ability to read write and comprehend English.
Experience and/or Background
- 3 - 5 years of related experience in Class II or Class III disposables medical product development.
- Design for Six Sigma (DFSS) training or certification preferred.
- Good understanding of change control management
- Exp in design transfer to manufacturing plans or some experience in the manufacturing side supplier relations understanding
Education :
- BS degree in any field will work.
- BS in Mechanical Plastics Biomedical Engineering or a related field MS preferred.
- With minimum of 2 years of relevant experience is required but atleast 3-5 years would be more appropriate.
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.
Employment Type
Full Time
Key Skills
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