Applied Medical is a new generation medical device company with a proven business model and commitment to innovation fueled by rapid business growth and expansion. Our company has been developing and manufacturing advanced surgical technologies for over 35 years and has earned a strong reputation for excellence in the healthcare field. Our unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute in a larger capacity than is possible in typical positions.
Position Description
The information systems (IS) Business Analyst will be responsible for the successful implementation of the custom Manufacturing Execution System (MES), known as the “Electronic Device History Record” (eDHR). Working closely with cross-functional teams, the Business Analyst will gather requirements, analyze business processes, and translate them into functional specifications for the MES implementation. The primary objective of this role is to streamline our manufacturing operations, improve efficiency and ensure compliance with regulatory standards.
As a Business Analyst for Information Systems, you will be responsible for working within the framework of a team and performing the following activities:
- Collaborate with stakeholders, including operations, quality assurance, production planning, and IT teams, to understand business needs and requirements for the eDHR system
- Conduct comprehensive analysis of existing business processes and identify areas for improvement and automation within the manufacturing environment
- Develop and document detailed functional specifications for the eDHR system, ensuring alignment with business goals, industry best practices, and regulatory requirements
- Work closely with Systems, Applications, and Products (SAP) experts and developers to configure and customize the MES solution based on the SAP Production Planning (SAP PP) back end
- Collaborate with project managers and technical teams to ensure successful implementation, including system integration, data migration, and testing
- Conduct user acceptance testing (UAT) and facilitate end-user training sessions to ensure effective adoption of the eDHR system
- Provide ongoing support, troubleshooting, and enhancements for the MES system post-implementation
- Stay up to date with industry trends and emerging technologies related to MES and manufacturing processes, recommending improvements and enhancements as appropriate
Position Requirements
This position requires the following skills and attributes:
- Minimum of three years’ experience as an IS Business Analyst
- Strong understanding of manufacturing processes and familiarity with SAP Production Planning or similar Enterprise Resource Planning (ERP) systems
- Solid knowledge of regulatory requirements, including Food and Drug Administration (FDA) regulations such as 21 Code of Federal Regulations (CFR) Part 11, International Organization for Standardization (ISO) standards like ISO 1348, and other pertinent quality and compliance standards
- Excellent analytical and problem-solving skills, with the ability to translate business requirements into technical specifications
- Strong communication and interpersonal skills to effectively collaborate with cross-functional teams and stakeholders at all levels
- Proven track record of successfully managing projects, adhering to timelines, and delivering high-quality results
- Ability to adapt to changing priorities and work in a fast-paced, dynamic environment
Preferred
The following skills and attributes are preferred:
- Three years’ experience as an IS Business Analyst in a manufacturing or medical device setting
- Experience in implementing or supporting a custom MES system
Join our team and contribute to the success of our organization by implementing a custom MES that will revolutionize our manufacturing operations. This position offers a competitive salary, benefits package and a dynamic work environment focused on innovation and excellence.
Benefits
The base compensation range for this role is $80000 – $135000 / year for the position in California. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. The range displayed reflects the minimum and maximum target for new hire salaries in California based on the date of this job posting. Your recruiter can share more about the specific salary range compensation package during your hiring process.
Please understand that the compensation range may be modified in the future. Each amount of pay is considered to be wages or compensation once such amount is earned and determinable. The amount and availability of any bonus, commission, benefit or any other form of compensation may be modified at the Company’s sole discretion, consistent with the law.
The total compensation package for this position may also include [bonuses and/or other applicable incentive compensation plans].
Our total reward package also includes the following:
- Training and mentorship with ongoing learning and development courses
- On-campus wellness activities
- Comprehensive medical and dental and vision coverage
- Education reimbursement program
- 401(k) program with discretionary employer match
- Generous vacation accrual and paid holiday schedule
All compensation and benefits are subject to the requirements and restrictions set forth in the applicable plan documents and any written agreements between the parties.
Equal Opportunity Employer
Applied Medical is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (including pregnancy, childbirth, breastfeeding and related medical conditions), or sexual orientation, or any other status protected by federal, state or local laws in the locations where Applied Medical operates.