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Senior R&D Systems Engineer

Req ID:  1243

Working Location: MASSACHUSETTS, SOUTHBOROUGH 

Are you looking for a company that cares about people’s lives and health, including yours? At Olympus, we help make people’s lives healthier, safer and more fulfilling, every day. 
 
Let’s inspire healthier lives, together.

Job Description

The Senior R&D Systems Engineer will support Systems Engineering aspects on new product development efforts within the Olympus Surgical Technologies of America (OSTA) organization.  The ideal candidate will be a hands-on project engineer with a strong systems design and integration background.  The primary responsibilities of this role will include support of all phases of device development with a focus on electrical and hardware engineering, software development and system engineering.   Within a collaborative team environment, it will be expected that he or she will be a proactive communicator, collaborate well with others, manage their work efficiently, produce high quality work and consistently seek additional knowledge and skills. They create technical data, data analysis, and subsequent reporting will be an important aspect of this role, as well as helping to generate all documents / deliverables that will comprise the Design History File. The successful candidate must have working knowledge of medical device design control requirements, system design and software and hardware integration and testing, and design for manufacturability and testability are required.  

Job Duties

* Provide project and technical leadership to cross functional teams including external partners for projects from conceptualization, development, product registration and through commercialization.
 

* Establish and foster strong collaborative relationships with internal and external design/development partners, manufacturing partners and service providers. Provide critique and design guidance to ensure proper implementation and traceability of design outputs as compared to design inputs.
 

* Support the requirements development and management process, incorporating risk management elements as required.
 

* Ensure compliance to product security and cyber security policies, and support efforts to author local SOP’s to ensure compliance.
 

* Support the optimization of design control elements to comply with medical device regulations.
 

* Implement product design with the intention of optimizing design for manufacturability and testability
 

* Consider Cost of Goods and lifecycle when selecting components for device designs.
 

* Develop engineering solutions, investigate competing technologies while considering the patent landscape, and protect engineering solutions by filing timely invention disclosures and working closely with the IP Legal team as needed.
 

*  Establish and maintain detailed project plans, define risks and recommend contingency plans as required.
 

* Provide support of Risk Management activities, working with Design Assurance 
 

* Utilize statistically sound approaches to design verification protocols/reports, design validation, and delivery system qualification activities
 

* Support the system safety certification process to standards such as EN60601-1, EN60601-1-2.  

 

* Ensure software is developed in compliance to the methodologies of EN 62304.
 

* Maintain knowledge of technical product landscape, competitive products and procedural trends for target procedural areas.

Job Requirements

REQUIRED QUALIFICATIONS:

 

* Bachelor’s degree in Electrical or Software Engineering

 

* Minimum years of related experience: Minimum 5 years with a Bachelor's degree; Minimum of 4 years with MS; Minimum 2 years with PhD.

 

PREFERRED QUALIFICATIONS:

 

* Experience in Medical Device development and/or sustaining engineering efforts utilizing a stage-gate process.  Experience in hand held electro-mechanical devices is preferred.

 

* Must have extensive working knowledge and application of FDA requirements, including 820CFR, ISO14971, IEC60601, GMP and other standards as they relate to the design and manufacture of medical devices.

 

* Capable of leading & developing many of the Design Control deliverables required to document a product design and establish compliance with Design Inputs with appropriate specificity and quality.

 

* Proficient in Microsoft Windows Office applications including MS Outlook, MS Powerpoint, MS Project, Visio, etc..

 

*  Knowledge of printed circuit board design and manufacturing processes. Experienced in developing schematics, selection of components, and current knowledge of developments in the electronics industry.

 

*  Working knowledge of printed circuit board design tools (e.g., Altium or OrCAD) and capability to evaluate and scrutinize designs and Gerber data. 


* Experience planning and mitigating system design issues (e.g., electromagnetic compatibility).

 

* Ability to effectively work within a requirements management system, such as Doors, JAMA, etc and perform hardware risk analyses and hardware DFMEAs.

 

* Experience in the practical application of statistics and working knowledge of a statistical analysis package (Minitab).


* Knowledge of software lifecycle management in compliance to EN62304.  Ability to evaluate software and software documents and provide effective feedback to development partners.

We realize work isn’t just a job to you.

It’s a big part of your life, but not the only part. That’s why we offer competitive salaries, a robust 401(k) program, annual bonus program and comprehensive medical benefits, as well as tuition reimbursement, flexible schedules, parental and adoption leave, on-site services and Colleague Affinity Networks — so you can be ready for where life can take you.

Olympus is passionate about the solutions it creates for the medical, life sciences, and industrial equipment industries, as well as cameras and audio products. For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling by helping detect, prevent, and treat disease, furthering scientific research, ensuring public safety, and capturing images of the world.

Olympus’ Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce overall costs, and enhance the quality of life for patients. Olympus’ Medical portfolio includes endoscopes, laparoscopes, and video imaging systems, as well as surgical energy devices, system integration solutions, medical services, and a wide range of endotherapy instruments for endoscopic and therapeutic applications. For more information, visit www.olympus-global.com.

Olympus…True To You. True To Society. True To LIFE.

 

It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.

Posting Notes: || United States (US) || Massachusetts (US-MA) || Southborough || 

 

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