OriGen Biomedical Open Jobs

POSITION SUMMARY

The Sustaining Engineer will support on-market Class I and Class II disposable, sterile medical devices with technical support, product training, improved processes, contingency planning, re-validation testing, 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.
• Prepare and lead design reviews for design changes.
• Support verification and validation planning activities for on-market devices, including supplier-initiated changes, material changes, design changes, etc.
• Plan and execute continuous improvement activities focused on quality improvement and cost reduction.
• 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.
• Perform Root Cause Analysis of product-related problems, plan, and implement corrective actions.
• 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.
• Other duties and/or projects as assigned

REQUIRED SKILLSETS

• Knowledge of FDA regulations and GMP guidelines for medical device process 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 and Excel.
• Proficient in computer-aided design (CAD), preferably SolidWorks, and statistical analysis software, preferably Excel and Minitab.
• 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, including fish-bone diagrams, 5-whys, FEMA
• Project Management
• Ethical Conduct
• Communication and interpersonal skills
• Strategic Thought
• Adaptability
• DOE and Validation testing
• Decision making
• Corrective and preventative actions
• Computer-aided design (CAD)
• Statistical analysis

MINIMUM QUALIFICATIONS (KNOWLEDGE, SKILLS, & ABILITIES)

• Bachelor’s degree in Engineering OR Bachelor’s degree in STEM and 4+ years’ experience in engineering principals of medical devices / ISO 13485 environment
• 3+ years of applicable experience in sustaining, development, or design engineering
• 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, specifically design control
• Knowledge of EU Medical Device Regulation (MDR)

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.

NOTE

This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent

in this position. Employees will be required to follow any other job-related instructions and to perform any other job-related

duties requested by any person authorized to give instructions or assignments. All duties and responsibilities are essential

functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities.

To perform this job successfully, the incumbents will possess the skills, aptitudes, and abilities to perform each duty

proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of

themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities. This

document does not create an employment contract, implied or otherwise, other than an “at-will” relationship.

Morning Shift: Work hours: five days, 8-hour shifts (Monday-Friday 5:30am – 2:00pm).

Evening Shift: Work hours: four days, 10-hour shifts (Monday-Thursday  2:15pm – 12:45am). 

The Clean Room Tech (CRT) is responsible for the assembly, testing, and packaging of medical devices and components. Required to understand and comply with drawings, written procedures, batch records, and must apply these standards to their work.

Essential Duties and Responsibilities

The essential duties and responsibilities of this position include, but are not limited to the following:

• Ability to meet production schedules and deadlines according to quality standards
• Ability to work in a flexible and changing environment
• Ability to follow detailed written and verbal instructions
• Ability to learn multiple tasks and train in other areas as needed
• Ability to work with a variety of tools and equipment
• Ability to maintain all logs, paperwork, and forms accurately
• Required to understand, access, and make entries to documents on the company Electronic Document System
• Ability to accurately perform job duties with minimum supervision
• Ability to adhere to cleanroom dress code and policies
• Ability to work in a multi-cultural team environment and be a team player
• Ability to work in a cleanroom environment for extended periods of time
• Punctual and Reliable!!

Required Skill Sets

• Must be detailed oriented and be able to focus on a repetitive task for long periods of time
• Must be proficient on a computer, possessing basic navigation and program knowledge
• Must be able to absorb, assimilate and accurately recall/locate and retain large quantities of data/information
• Must be able to read, write, speak and fully understand English

Competencies

• Adaptability/Flexibility
• Ethical Conduct/Integrity
• Communication/Listening
• Detail-Oriented
• Interpersonal skills
• Personal Effectiveness
• Teamwork

Minimum Qualifications (Knowledge, Skills, and Abilities)

• Basic computer navigation and program knowledge
• Strong organization and time management skills with the demonstrated ability to meet deadlines
• Pays very close attention to detail
• Ability to work independently and within a team environment  

Preferred Qualifications

• Prior Clean Room experience preferred

Compensation

Based on experience and ability

How to Apply

Interested candidates should send their resume, title(s) of job for which they wish to be considered, and salary requirements to origenjobs@origen.com. Unfortunately, due to the volume of candidates, it is not possible to follow up with all applicants, but we invite you to visit OriGen’s Career Page often, as we are updating with new opportunities frequently.  We look forward to hearing from you.

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