Senior Mechanical Engineer

Quality Engineer

Ximedica is an ISO 13485 certified and FDA registered full-service product development firm with offices in Providence, Minneapolis, and Hong Kong. We have an exclusive focus on medical products and over 25 years of experience developing medical devices, combination products and consumer healthcare products.

We have a high-energy collaborative culture that fosters the creative spirit while exceeding client expectations. We offer tremendous opportunity for professional development and leadership, rewarding projects, competitive salaries, an excellent benefits package, and summer hours. 

The Quality Engineer applies best practices from within the field of quality control to ensure that the materials, components, processes, and manufacturing techniques used produce high quality and reliable products. They review design or process changes for impact to quality, and the design history file.

Nature of Role: Reporting to the Director of Quality Services, this ‘go-to’ resource stays abreast of current quality and regulatory trends and ensures the successful integration of quality assurance and regulatory compliance, working across multiple teams and medical device/equipment categories

Requirements: 

Our fast-paced environment demands the ability to manage multiple projects within various disciplines and deadlines. High-energy, self-starters with the following qualities:

Responsibilities: 

Talent Acquisition Manager

Ximedica is a contract design, development and manufacturing company specializing in medical devices, instruments, and technologies. Ximedica participates in the entire development process from initial design exploration to supply of finished goods. Its core competencies include mechanical and electronic design as well as firmware and software implementation. In addition, Ximedica offers design control, compliance-related documentation tracking and offshore sourcing of components and subassemblies.

The Talent Acquisition Manager should have a minimum of 5 years of experience in talent acquisition and be able to develop recruiting strategies and leverage understanding of the business’ workforce planning needs to support talent acquisition strategies to attract and hire a diverse, best-in-class talent for the organization. Reporting to the VP of Human Resources, the Talent Acquisition Manager is responsible for collaborating with internal subject matter experts to oversee the full life cycle recruiting, utilizing standard and creative sourcing, evaluating and screening resumes, completing phone screens & interviews to determine if a selected candidate(s) meets position requirements, and extending offers and closing candidates.

Responsibilities:

Requirements: High-energy, self-starters with the following qualities are encouraged to apply:

Training & Development Manager

Ximedica is a contract design, development and manufacturing company specializing in medical devices, instruments, and technologies. Ximedica participates in the entire development process from initial design exploration to supply of finished goods. Its core competencies include mechanical and electronic design as well as firmware and software implementation. In addition, Ximedica offers design control, compliance-related documentation tracking and offshore sourcing of components and subassemblies.

The Training and Development Manager, reporting to the Sr. VP of Operations, is responsible for collaborating with internal subject matter experts to generate effective training materials that can be deployed across the company efficiently. Training material to be generated and managed will include but not limited to business operations, program management, software, quality management system, Leadership and development. The manager is also responsible for the coordination of the new employee on-boarding program and owns the associated continuous improvement initiatives. The manager also assists in the administration of the program for professional development of employees. Depending on the particular training, assisting in deployment of the training is expected and occasional travel may be required.

Requirements: Our fast-paced environment demands the ability to manage multiple projects within various disciplines and deadlines. High-energy, self-starters with the following qualities are encouraged to apply:

Responsibilities:

Sr. Design Assurance Engineer

The Senior Design Assurance Engineer provides leadership and input to our contract development teams in the design of highly complex medical devices.  They ensure that compliance to customer, risk management, quality, and Design Control requirements is demonstrated and help to ensure successful transfer of the design to manufacturing.  They are responsible for accurate and independent generation and evaluation of Design History File documentation and overall Quality System compliance. They also help guide and mentor other team members in a collaborative environment.

Nature of Role:  Reporting to the Head of Quality Services, this ‘go-to’ resource stays abreast of current quality and regulatory trends and ensures the successful integration of design assurance and regulatory compliance, working across multiple teams and medical device/equipment categories.

Requirements:

Responsibilities:  

Senior Mechanical Engineer

Associate Network Technician

Sr. Program Manager

The Senior Program Manager has a Bachelor of Science degree in an engineering discipline and 8+ years of experience in consumer product development, diagnostics and/or medical equipment and device development or its equivalent. Reporting to Head of Program Management, this individual manages and executes program direction in accordance with the client and development team goals. In addition, this individual has experience with leading and directing business development initiatives regarding specific clients. The Sr. Program Manager will be responsible for managing major/complex programs and leading various disciplines in executing the required deliverables. It is expected that these programs require discipline leaders and multiple team interfaces. The ability to interact with clients from project initiation through the entire development process is a must. The following key attributes are required:

• Flexibility to perform and manage a wide range of activities and willingness to “wear many hats”

• Outstanding people skills; friendly, confident, competent, great communicator, honest, and sincere

• Must be a dynamic personality and willing to work within a collaborative team environment

• Energetic, proactive self-starter who enjoys challenges and variety

Responsibilities:

• Client /Team Management responsibility including overall client satisfaction, profitability, etc. and that client program is maintained. Awareness of client satisfaction level and client needs for differing levels of service.

o Maintain program oversight over all disciplines. Ensure individual discipline leaders are aware of client overall objectives and their responsibilities to the specific programs. Escalate any issues as appropriate to higher level management.

• Sound program management skills, including task scheduling, budget tracking,

o Develop and Maintain schedule, including resource needs to accomplish tasks.

o Ensure program profitability, and that proposal deliverables are completed on time and within budget

o Ensure program is compliant with the Ximedica product development process, including Ximedica’s SOP’s guidelines.

o Ensure that any out of scope work is approved by either the client and/or internally.

o Advocate and maintain appropriate resource loadings needed to maintain project deliverables, including budget and schedule.

o Conduct post-mortem with team members and appropriate senior management on each phase during the program

• Ability to organize and communicate high-level presentations to clients, clinicians, and participating teams, as necessary

o Develop with team, appropriate presentations of activities during each phase of program. Ensure that each presentation is reviewed internally by management prior to submitting to client/other.

o Maintain day-to-day relationships with client companies o Submit weekly project status dashboards to internal management and/or client.

o Ensure meeting agendas are submitted prior to and utilized during meetings.

• Demonstrated ability to direct and manage resources, make decisions, solve problem, exercise good judgment & flexibility and maintain budgets and schedule

o Ensure that each team member is aware in writing the time (work effort and duration) allotted for activities.

o Coordinate all aspects of program activities, between the client and Ximedica industrial design, engineering, quality, regulatory, testing, documentation, etc.

• Ability to communicate with vendors and to proactively monitor internal resources to ensure all products are developed within cost targets and delivered on schedule

• Ensure Ximedica is meeting the needs of the client and that the device will be successful in the marketplace Medical Specific:

• Familiarity in the design of complex medical capital equipment as well as disposable devices

• Familiarity with appropriate FDA, QSR, and ISO regulations: design controls, document controls, design verification and validation, hazard analysis techniques, regulatory approval methods, and overall medical device industry knowledge

• Manage the design and development of complex electro-mechanical medical devices and equipment

Other experience:

• Experience with Agile product development processes and tools

• Experience with a variety of manufacturing processes, including injection molding of plastics, machining methods, rapid prototyping techniques, sheet metal fabrication, etc.

• Experience in leading concept generation activities.

• Understanding of Human Centered Industrial Design & Usability research activities and their interface with engineering.

• Understanding of mechanical engineering development processes, utilizing 3D CAD or related engineering software techniques

• Understanding of electronics and software development

• Understanding of Voice of the Customer and User Needs research activities and processes.

Human Factors Engineer

Design Researcher

Senior Systems Engineer

Program Manager

The Program Manager has a Bachelor of Science Degree and a minimum of 5 years of experience in consumer product development, diagnostics, and/or medical equipment and device development or its equivalent experience.

Nature of Role:

Reporting to the Director of Program Management, this individual manages and executes program direction in accordance with the client and development team goals. The following key attributes are required:

Responsibilities:

General:

Medical Specific:

Other experience:

Senior Software Engineer

Ximedica is an ISO 13485:2012 certified and FDA registered full-service product development firm with offices in Providence, St. Paul, San Francisco, and Hong Kong. We have an exclusive focus on medical products and over 25 years of experience developing medical devices, combination products and consumer healthcare products.

We have a close-knit, high-energy culture that fosters the creative spirit while exceeding client expectations. We offer tremendous opportunity for professional development and leadership, rewarding projects, competitive salaries, an excellent benefits package, and summer hours. Opportunities are currently available in both our Providence, RI and Minneapolis, MN facilities.

Position:

The experienced Senior Software Engineer supports our rapidly growing domestic and international product development, sourcing, and manufacturing business.

Nature of Role:

Reporting to the Director of Software & Electrical Engineering, the Senior Software Engineer works with the Electrical Engineering team and leads the firmware design effort’s of Ximedica’s product development programs.

Requirements:

A Bachelor’s degree in Computer Science/Engineering, coupled with 5-10 years of experience in embedded systems development within the medical device arena is required along with the following key attributes:

Our fast-paced environment demands the ability to manage multiple projects within various disciplines and deadlines. High-energy, self-starters with the following qualities:

Responsibilities: