Staff Process Engineer in Allendale, NJ bei Stryker Corporation

Datum der Veröffentlichung: 7/7/2019

Stellenauszug

Stellenbeschreibung

The Staff Engineer essential duties and responsibilities include:

  • Understand the company’s internal workings and develop processes for efficient functioning.
  • Lead and direct engineering process development to maximize cost and project efficiencies, process improvements and on-time delivery.
  • Evaluates current engineering processes and develop, implement and maintain all changes with consideration of long term Lean Production system design and techniques.
  • Develops, monitors, and routinely improves engineering and process standards across the organization.
  • Drives processes development to optimize efficient process flow and reduce process variability.
  • Manage the development of new products and engineering processes using existing and emerging technologies in accordance with design control requirements.
  • Contribute to the development and/or of authorization of SOPs, operational procedures, engineering drawings, test reports, MRB decisions, design control procedures, and other related documents.
  • Manage and maintain legacy product, processes, and systems.
  • Develop and drive cross functional metrics to monitor and collect data on processes and systems.
  • Contribute to the effective documentation and implementation of product development processes, procedures, and forms to assure compliance with worldwide regulatory agencies.
  • Communicates customer, regulatory and organizational requirements to assure product quality, contract compliance and customer satisfaction.
  • Responsible for assuring conformance of all with FDA/ISO regulations and requirements with regards to product development and design.
  • Responsible for developing, implementing and monitoring a fully compliant process for developing products.
  • Ensure progress is made toward new product compliance deliverables, objectives, and timelines.
  • Attain and share knowledge of the latest regulations and standards by participating in education opportunities and professional organizations, and reading professional publications.
  • Support regulatory submissions including 510k and CE mark.

Knowledge, Skills, and Abilities required:

  • Demonstrates a complete ability to apply engineering principles to business environment as appropriate for this level.
  • Demonstrated leadership, project management, and facilitation and problem-solving skills.
  • Must demonstrate effective verbal and written communication skills.
  • Must demonstrate the ability to evaluate systems and procedures and recommend new efficient and effective processes.
  • Possess strong problem-solving skills and decision-making ability.
  • Possess a record of successful experience in management of engineering projects that has produced successful documented results.
  • Must have a strong and proven track record of effective, organized, thoughtful team leadership.
  • Clear understanding of quality standards, regulatory pathways, and manufacturing operations.
  • Must have a demonstrated and polished ability to effectively and clearly communicate concepts, ideas and knowledge to other individuals and teams.
  • Must have advanced ability to professionally and effectively present information to, and receive feedback from staff as well as external partners..
  • Complete understanding of quality standards, regulatory pathways, and manufacturing operations and how those departments relate to R&D engineering.
  • Experience working with ISO requirements, GMP guidelines, FDA regulations, medical device design control, and manufacturing scale-up processes.
  • Comfortable working with and seeking optimum solutions with multi-disciplinary teams, including engineering, regulatory, clinical, quality, marketing, and manufacturing.
  • Must be able to anticipate project and process design related issues and take steps to mitigate these risks.
  • Must have current knowledge of policy updates and changes from the FDA and ISO and keeping K2M corporate management aware.
  • Write and implement procedures and specifications as necessary to assure effective compliance with FDA, ISO and other applicable regulations and standards.
  • Provide reports to the Executive staff on the status of engineering systems, processes, and programs.
  • Control and oversee maintenance of all documentation and processes involved in the engineering systems i.e. Device Master and Design History.
  • Review product technical files for accuracy and compliance with the ISO and individual country standards. Develop clinical and regulatory summaries.

Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed here are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with
disabilities to perform the essential functions.


Education/Experience:

  • Bachelor’s degree (B.A) in Mechanical or Biomedical Engineering from an accredited college or university.
  • Master’s Degree or MBA Preferred.
  • Minimum of 7 years of experience in a related field.
  • Minimum of 5 years of experience in a regulated industry. Medical device/technology preferred.

Language Ability:
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond
to questions from groups of managers, surgeons, customers, vendors, and general public.

Math Ability:
Ability to perform basic calculations using a calculator. Ability to use tools like spreadsheets to aid in the concepts such as probability and statistical metrics. Ability to apply concepts such as fractions, percentages, ratios and proportions to practical situations.


Reasoning Ability:
Ability to solve practical problems and deal with a variety of variables in situations where limited standardization exists. Ability to define problems, collect data, establish facts, and draw valid conclusions.


Computer Skills:
Proficient in Microsoft Word, PowerPoint, Excel, Solidworks, Creo, or other CAD Systems.

Work From Home: No

Travel Percentage: None

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

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