Top 568 Medical device development engineer Jobs in Austin, Tx

Sustaining Engineer I
OriGen Biomedical —Austin, TX
- Microsoft Word
- Microsoft Excel
- Engineering
Quick Apply
Chemical Engineer
Siemens Healthineers —Austin, TX
- $72,860 - $100,188 a year
- Full-time
- Bachelor of Science
- Mid-level
- Bachelor's degree
- Disability insurance
- Health insurance
12d
Process Development Engineer
Fab2 —Austin, TX
- $90,000 - $180,000 a year
- Full-time
- Bachelor of Science
- Doctor of Philosophy
- Senior level
- Commuter assistance
- Paid parental leave
Mechanical Engineer
Siemens Healthineers —Austin, TX
- $72,860 - $100,188 a year
- Full-time
- Bachelor of Science
- Laboratory experience
- Mid-level
- Disability insurance
- Health insurance
12d
Clinical Scientist
Neuralink —Austin, TX
- $108,000 - $200,000 a year
- Full-time
- 5 years
- Mid-level
- Analysis skills
- Commuter assistance
- Paid holidays
Quality Systems Engineer
Neuralink —Austin, TX
- $71,000 - $119,000 a year
- Full-time
- Engineering
- Mid-level
- Analysis skills
- Commuter assistance
- Paid holidays
11d
Quality Engineer I
Thermo Fisher Scientific —Austin, TX
- Full-time
- Background check
- Pass drug screening
- No experience needed
Sr Product Quality Engineer - Onsite
Siemens Healthineers —Austin, TX
- $112,420 - $154,572 a year
- Full-time
- Engineering
- Master's degree
- Experience equivalent to degree accepted
- Disability insurance
- Health insurance
Systems Engineer
Enovis —Austin, TX
- Full-time
- Laboratory
- Computer Science
- Office
- Health insurance
- Dental insurance
Quality Engineer II
Thermo Fisher Scientific —Austin, TX
- Full-time
- Background check
- Pass drug screening
- No experience needed
R&D Device Engineer
Fab2 —Austin, TX
- $110,000 - $180,000 a year
- Full-time
- Office
- Doctor of Philosophy
- Senior level
- Commuter assistance
- Paid parental leave
Optical Engineer
TransWave Photonics, LLC —Austin, TX
- $90,000 - $120,000 a year
- Full-time
- Background check
- Mid-level
- 3 years
- Relocation assistance
- Health insurance
Quick Apply
Quality Control Scientist
MilliporeSigma —Round Rock, TX
- $35 - $38 an hour
- Full-time
- Bachelor of Science
- Mid-level
- Bachelor's degree
Quick Apply
4d
Staff Quality Engineer
Nuclein —Austin, TX
- Full-time
- Management
- Bachelor of Science
- Travel
Senior Customer QA Engineer
SkyWater Technology Foundry, Inc. —Austin, TX
- Full-time
- 5 years
- Bachelor of Science
- Analysis skills
- Paid holidays
- Disability insurance
Quick Apply
Lead PLC Control Technician
Divcon Controls —Texas
- Full-time
- Management
- Ability to walk for extended periods
- Ability to climb stairs
- Paid training
- Disability insurance
Quick Apply
Forensics Lab Infrastructure Engineer (Hybrid)
CrowdStrike —Austin, TX
- $118,000 - $212,000 a year
- On call
- System design
- Continuous improvement
- Senior level
- Paid holidays
- Health insurance
1d
Embedded Software Engineer - RF and FPGA Systems (JC910)
ilocatum —Austin, TX
- $90,000 - $130,000 a year
- Full-time
- Computer science
- Computer Science
- Mid-level
- Paid holidays
- Health insurance
Quick Apply
Mammography Technologist II
Baylor Scott & White Health —Austin, TX
- Full-time
- Hospital
- Inventory management
- Customer service
- Health insurance
- Tuition reimbursement
RF Analog Design Engineer - Analog and Mixed Signal Systems (JC910)
ilocatum —Austin, TX
- $110,000 - $160,000 a year
- Full-time
- Mid-level
- Analysis skills
- Mentoring
- Paid holidays
- Relocation assistance
Quick Apply

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medical device development engineer jobs near austin, tx

Sustaining Engineer I

OriGen Biomedical -
Austin, TX

Quick Apply

Job Details

Qualifications

Microsoft Word
Microsoft Excel
ISO standards
Technical writing experience within manufacturing
CAD design (engineering design task)
Collaboration with product development teams
Leading team collaboration initiatives
Quality standards in production
Collaboration with manufacturing teams
Biomedical regulatory compliance
Cross-functional team management
Cross-functional communication
FDA regulations

Full Job Description

COMPANY
OriGen Biomedical, Inc., is a global leader in cryopreservation and cell culture. We collaborate with top
researchers, clinicians, and business partners to enhance solutions, improve patient outcomes, and achieve
customer satisfaction by providing safe and effective products that positively impact the quality of life.

POSITION SUMMARY
The Sustaining Engineer level I will support on-market Class I and Class II disposable, sterile medical devices with
technical support, product training, improved processes, contingency planning, and implementation of cost savings

initiatives. The sustaining engineer will assist both manufacturing and development engineers to maintain our on-
market devices.

ESSENTIAL DUTIES AND RESPONSIBILITIES

The essential duties and responsibilities of this position include, but are not limited to the following:
Draft and execute test protocols to demonstrate product capabilities that meet customer needs.
Manage the design history files of on-market devices and keep to state-of-the-art standards.
Consult with marketing and regulatory to identify new markets for devices and plan new validation and testing activities as necessary.
Assess risk to the design, manufacturing process, and use of on-market devices.
Execute risk mitigation activities to reduce risk to patients as far as possible and document to current standards.
Assist in complaint and discrepant material investigations with good documentation and reporting.
Create supply-chain contingency plans for critical raw material components of on-market devices.
Assist Development Engineering with variant development projects of on-market devices including preparation of cost estimations, drawings, and samples.
Provide product technical support to account managers and customer service.
Train manufacturing technicians and quality inspectors to the use of products.
Establish and maintain standards for released drawings and material specifications.
Review revisions to Standard Operating Procedures and manufacturing instructions.
Evaluate and document process risks that tie into validation.
Perform Root Cause Analysis of product-related problems, plan, and implement corrective actions.
Other duties and/or projects as assigned

REQUIRED SKILLSETS
Knowledge of FDA regulations and GMP guidelines for medical device validation.
Proven skills in coordinating and managing day to day tasks and working in collaboration to accomplish
deadlines and objectives.
Proficiency in technical and layman writing.
Works in cross functional teams to complete projects and testing.
Knowledge of and skills in using computer software and hardware applications, including Microsoft Word,
CAD, and Excel.
Outstanding communication skills, both written and oral, and will be expected to communicate directly with
production management, production technicians, engineers, and senior management.

COMPETENCIES

Self-motivated
Broad creativity and curiosity
Problem-solving skills
Computer Aided Design software (e.g. SolidWorks)
Project Management
Ethical Conduct
Communication and interpersonal skills
Strategic Thought
Adaptability
DOE and Validation testing
Decision making
Corrective and preventative actions

MINIMUM QUALIFICATIONS (KNOWLEDGE, SKILLS, & ABILITIES)

Bachelor’s degree in Engineering OR 4+ years’ experience in engineering principals of medical devices /ISO 13485 environment
Demonstrated ability to use effective and results-oriented problem solving and critical thinking skills; strong troubleshoot ability
Strong interpersonal and people skills
Strong organization and time management skills with the demonstrated ability to meet deadlines
Strong and effective communication skills (verbal and written)
Close attention to detail
Ability to work independently and lead or participate in a cross-functional team environment

PREFERRED QUALIFICATIONS

ISO 13485 experience

SUPERVISORY RESPONSIBILITY
This position has no supervisory responsibilities. This position may be required to lead/report on projects and
ensure participants meet deadlines.

WORK ENVIRONMENT
This job operates in a climate-controlled warehouse and/or professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines. The noise level in the work environment is generally moderate however periods of higher-level noise may occur. This job may also operate in a cleanroom environment. The cleanroom environment requires personnel to wear personal clothing completely covering the legs; company-provided cleanroom attire; e.g. coat, bouffant, face mask, and gloves.

Must be able to stand or sit for extended periods. Must be able to wear personal protective equipment when required

PHYSICAL DEMANDS & WORK ENVIRONMENT
The physical demands described here are representative of those that must be met by an employee to successfully
perform the essential job duties and responsibilities of this position. Reasonable accommodations may be made to
enable individuals with disabilities to perform the functions.
While performing the duties of this position, the employee is regularly required to talk and hear. The employee is
frequently required to use hands, fingers, handle or feel objects, tools, or controls. The employee is frequently
required to stand, walk, climb, sit, stoop, bend, and reach with hands and arms. The employee must frequently lift
and/or move up to 50 pounds and may be required to operate automated warehouse equipment; e.g. electric pallet
jack, or forklift. Specific vision abilities required by this position include close vision, distance vision, color vision,
and the ability to adjust focus.

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Refine Your Search

medical device development engineer jobs in austin, tx

Sustaining Engineer I

Chemical Engineer

Process Development Engineer

Mechanical Engineer

Clinical Scientist

Quality Systems Engineer

Quality Engineer I

Sr Product Quality Engineer - Onsite

Systems Engineer

Quality Engineer II

R&D Device Engineer

Optical Engineer

Quality Control Scientist

Staff Quality Engineer

Senior Customer QA Engineer

Lead PLC Control Technician

Forensics Lab Infrastructure Engineer (Hybrid)

Embedded Software Engineer - RF and FPGA Systems (JC910)

Mammography Technologist II

RF Analog Design Engineer - Analog and Mixed Signal Systems (JC910)

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