Summary of Major Responsibilities
The Sustaining Engineer will ensure product support exists for installed base products of Exact Sciences instrument. This position will be instrument production and services centric. In this role, the Sustaining Engineer will ensure that Exact Sciences instrument performance specifications can be maintained throughout the product lifecycle. This position actively participates on Research/ Development and System Engineering project teams to ensure instrument production and serviceability. The Sustaining Engineer interfaces daily with all elements of the Exact Sciences business.
Essential Duties and Responsibilities
- Maintain manufacturing work instructions for production personnel.
- Assist the Technical Services Engineer in identifying appropriate Field Replacement Units (FRU) and release FRU and related documents for service organizations
- Manage product changes (COs) to ensure correct implementation of changes into production.
- Conduct review and disposition of Non-Conforming Materials Reports (NCMRs) to promote resolution of material issues, including the promotion of timely corrective action by the supplier(s).
- Interface and support regulatory affairs as required to investigate Out-of-Box (OOB) failures.
- Maintain production processes and facilities in accordance with the FDA, QSR, and ISO 13485 medical device.
- Maintain and assist with development of production fixtures and tooling.
- Work with the Laboratory Instrument Production Manager and Environment Health & Safety (EHS) team to implement special facility controls that may be required, such as Electrostatic Discharge (ESD), cleanliness, etc.
- Document and control test processes, maintaining and developing same for low complexity processes.
- Provide in-depth regulatory affairs support as required, e.g., supporting complaints investigation.
- Provide engineering support for the repair center, including tooling and procedures.
- Investigate field failures and feedback and identify root cause, research, suggest and implement hardware product enhancements that would improve field reliability of the product within the form/fit/function of the existing design.
- Address part obsolescence and sourcing / redesign of obsolete parts through testing and documentation.
- Plan for product lifecycle/obsolescence.
- Support supplier transfers if needed (verified through first article and/or product testing).
- Flexibility in schedule is required in this role to serve the needs of the customer or the organization. A traditional schedule will be the norm during most workdays.
- Other duties as required.
- Some travel may be required, less than 10%.
- Excellent oral and written communication skills, with strong attention to detail and record keeping skills required in a GMP environment.
Preferred Qualifications (optional)
- Skills and aptitude to lead projects and coordinate work of others.
- Good written and verbal communication skills, with all levels of employees, suppliers, and customers.
- Experience with personal computer systems, including enterprise resource planning (e.g., SAP, Oracle), web applications, MS Office, and Minitab is desirable.
- Experience in writing, reading and interpreting the documentation of designs and production processes.
- Experience using tools such as Agile and OrCAD is preferred.
- Experience with constructional data forms and electrical standards is desirable.
- Experience in product testing and calibration control processes, developing and using test equipment, troubleshooting and problem solving.
- Experience in ESD and cleanliness special control processes.
- Medical device manufacturing experience is desirable.
- Experience with safety and health (OSHA), FDA and ISO 13485 quality system requirements.
Education and Experience
- Bachelor of Science degree in an engineering field.
- Three to Five years of engineering experience working in manufacturing or engineering activities applying problem solving skills (e.g., Six Sigma, probability and statistics) and process improvement (e.g., Lean)
- Proven ability to frequently communicate with customers, and vendors in person, via the telephone and by email.
- Frequent grasping and use of fine motor skills.
- Occasional standing, walking, stooping, kneeling or crouching.
- Frequent use of safety protective gear/equipment (e.g. safety glasses, lab coat, gloves, respirator, etc.) as required.
- Occasional use of hazardous materials.
- Continuous repetitive movement of hands and fingers while working with computers or instruments.
- Frequent standing and/or sitting.
- Occasional travel by land and air.
- Frequently lifts, carries or otherwise moves and positions objects weighting 0-40 lbs.
Exact Sciences is an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. The Company’s affirmative action program is available to any applicant or employee for inspection upon request.
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