Thank you for your interest in Focus Surgery. We currently have the following openings:
Senior Quality & Validation Engineer
Focus Surgery, Inc., a leader in the development of cutting edge medical devices utilizing High Intensity Focused Ultrasound (HIFU), is looking for an experienced Senior Quality / Validation Engineer to join its team of skilled professionals.
This position will be responsible for the support, manufacture, and advancements of Focus Surgery products. Candidates should have experience in ensuring quality and compliance using design controls, FMEA’s and risk analysis. Experience working with medical devices with FDA approval and CE-Mark is highly recommended.
Essential Functions:
 | Experience
managing quality systems including:
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| Compliance regulatory requirements and management of engineering development procedures. | ||||||||
| Quality assurance, coordination, service support and training | ||||||||
| Experience with product design | ||||||||
| Manufacturing resources management | ||||||||
| Product enhancements/improvements, |
Job Qualifications/Requirements:
| Masters or Ph.D. Degree in Engineering & Science |
| Minimum of 5 years working experience in medical device manufacturing along with GMP, ISO, and other current regulatory standards. |
| Knowledge of manufacturing operations, scheduling, and project management. |
| Good communication skills and Experience with CAD systems (Solidworks, OrCad, etc) |
Software Engineer
Focus Surgery, Inc., a leader in the development of cutting edge medical devices utilizing High Intensity Focused Ultrasound (HIFU), is looking for an experienced Software Engineer to join its team of skilled professionals.
This position will be responsible for providing programming expertise as part of Focus Surgery’s product development team. The position is responsible for the entire software life cycle, from early “concept” discussions with the clinical staff through final testing and software maintenance.
Experience working with medical devices with FDA approval and CE Mark is highly recommended.
Essential Functions:
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Design, develop and testing/validation of:
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Assist Electrical Engineers with design and testing of custom electronics | ||||||
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Assist Technicians with system integration and troubleshooting | ||||||
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Coordinate the activities of software consultants | ||||||
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Develop and maintain software documentation | ||||||
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Assist technicians and distributors with field support |
Job Qualifications/Requirements:
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Bachelors degree in Computer Science or similar major | ||||||
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Experience on hardware/software development teams | ||||||
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Experience with Java, C++, and Windows Environments | ||||||
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Experience with international standards for quality systems beneficial | ||||||
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Ideally the candidate will also have
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Good communication and team skills |
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Candidates ideally will have 3+ years experience in a medical device environment |
Focus Surgery is committed to providing team members with:
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A dynamic, engaging work environment |
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Opportunities for career growth |
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Industry competitive compensation packages |
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A wide range of benefits including health, dental, vision and 401(k) |
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Flexible work schedules and time off plans |
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A comfortable, business casual work environment |
Let us know if you want to be part of the team!
Please send all inquiries and/or resumes to the following address:
Focus Surgery, Inc.
3940 Pendleton Way
Indianapolis, IN 46226
Tel: (317) 541-1580
Fax: (317) 541-1581
or by email to: HR@focus-surgery.com
If you are submitting a resume, please be sure to include a cover letter.
The Sonablate® is an investigational device limited by Federal Law to investigational use in the United States.